Role of Ultrasound and Cross-Sectional Imaging (CT and MRI) in the Characterization of Ovarian Neoplasms: A Prospective Diagnostic Accuracy Study give me Appendices of this thesis topic for synopsis of md radiology
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Here is a complete set of Appendices for your MD Radiology synopsis on this topic. These are structured to meet the standard requirements of most Indian medical university postgraduate synopsis formats (MCI/NMC guidelines).
APPENDICES
APPENDIX I: PROFORMA / DATA COLLECTION SHEET
Study Title: Role of Ultrasound and Cross-Sectional Imaging (CT and MRI) in the Characterization of Ovarian Neoplasms: A Prospective Diagnostic Accuracy Study
PATIENT IDENTIFICATION
| Field | Details |
|---|---|
| Serial No. | |
| Hospital Registration No. | |
| Name (Initials) | |
| Age (years) | |
| Date of Admission | |
| Date of Imaging |
CLINICAL DETAILS
- Chief Complaint: _______________
- Duration of symptoms: _______________
- Menopausal status: Pre-menopausal / Peri-menopausal / Post-menopausal
- Last Menstrual Period (LMP): _______________
- Parity: G__ P__ L__ A__
- Previous pelvic surgery: Yes / No (if yes, details): _______________
- Family history of ovarian / breast / colorectal cancer: Yes / No
- Serum CA-125 (U/mL): _______________
- Serum CEA, AFP, LDH, beta-hCG (if done): _______________
- Risk of Malignancy Index (RMI): _______________
ULTRASOUND FINDINGS (Transabdominal + Transvaginal)
Lesion Characteristics (IOTA Terminology):
| Parameter | Finding |
|---|---|
| Side (Right / Left / Bilateral) | |
| Unilocular / Multilocular / Solid / Mixed | |
| Maximum diameter (cm) | |
| Wall thickness (mm): thin (<3 mm) / thick (≥3 mm) | |
| Septa: Absent / Present; thin (<3 mm) / thick (≥3 mm) | |
| Papillary projections: Absent / Present; No. of projections | |
| Acoustic shadowing: Present / Absent | |
| Internal echogenicity: Anechoic / Low / Ground-glass / Mixed / Hyperechoic | |
| Ascites: None / Mild / Moderate / Massive | |
| Peritoneal deposits: Absent / Present |
IOTA Simple Rules:
- Malignant features (M-features): M1 / M2 / M3 / M4 / M5 (mark all that apply)
- Benign features (B-features): B1 / B2 / B3 / B4 / B5 (mark all that apply)
- Simple Rules result: Benign / Malignant / Inconclusive
IOTA ADNEX Model Risk Score: _______%
Colour Doppler:
- Vascularity: Absent / Present (central / peripheral / both)
- Resistive Index (RI): ___________
- Pulsatility Index (PI): ___________
- Peak Systolic Velocity (PSV): ___________
O-RADS Ultrasound Category (0-5): ___________
CT FINDINGS (Contrast-Enhanced CT Abdomen and Pelvis)
| Parameter | Finding |
|---|---|
| Lesion size (cm) | |
| Morphology: Cystic / Solid / Mixed | |
| Density (HU): Pre-contrast / Post-contrast | |
| Enhancement pattern | |
| Fat content (HU < -20): Present / Absent | |
| Calcification: Present / Absent | |
| Septations: Present / Absent; No./Thickness | |
| Mural nodules / Papillary projections | |
| Peritoneal deposits: Present / Absent | |
| Ascites: Present / Absent | |
| Lymphadenopathy: Present / Absent; stations | |
| Hydronephrosis: Present / Absent | |
| Adjacent organ invasion | |
| Liver / other distant metastases |
MRI FINDINGS (1.5T / 3T MRI Pelvis with contrast)
Protocol used: T1W / T2W / DWI / DCE / Fat-saturation
| Parameter | Finding |
|---|---|
| Lesion size (cm) | |
| T1 signal: Hypointense / Isointense / Hyperintense / Fat-signal | |
| T2 signal: Hypointense (dark) / Intermediate / Hyperintense | |
| T2 dark spot / T2 shading: Present / Absent | |
| DWI restriction: Present / Absent; ADC value (x10⁻³ mm²/s) | |
| Enhancement pattern on DCE: Type I (progressive) / Type II (plateau) / Type III (wash-out) | |
| Papillary projections: Absent / Present | |
| Mural nodules: Absent / Present | |
| Septae characteristics | |
| Ascites / Peritoneal deposits | |
| Lymphadenopathy |
O-RADS MRI Category (0-5): ___________
Radiological Impression: Benign / Borderline / Malignant / Indeterminate
HISTOPATHOLOGICAL FINDINGS (Reference Standard)
- Surgical procedure: Cystectomy / Salpingo-oophorectomy / TAH+BSO / Laparoscopy / USG-guided biopsy
- Gross pathology: _______________
- Microscopic diagnosis: _______________
- WHO Classification: _______________
- FIGO Stage (if malignant): _______________
- Concordance with imaging: Yes / No
APPENDIX II: O-RADS ULTRASOUND SCORING SYSTEM (ACR 2020)
(To be referenced during image reporting)
| O-RADS Category | Description | Malignancy Risk |
|---|---|---|
| 0 | Incomplete evaluation | - |
| 1 | Normal ovary / physiological | Almost 0% |
| 2 | Almost certainly benign | <1% |
| 3 | Low risk of malignancy | 1-10% |
| 4 | Intermediate risk | 10-50% |
| 5 | High risk of malignancy | >50% |
M-features (malignant):
- M1: Irregular solid tumour
- M2: Ascites
- M3: At least four papillary structures
- M4: Irregular multilocular-solid tumour with largest diameter ≥100 mm
- M5: Very high vascularity (colour score 4)
B-features (benign):
- B1: Unilocular cyst
- B2: Presence of solid components where the largest solid component is <7 mm
- B3: Acoustic shadowing
- B4: Smooth multilocular tumour with largest diameter <100 mm
- B5: No blood flow (colour score 1)
APPENDIX III: O-RADS MRI SCORING SYSTEM (ACR 2020)
| O-RADS MRI Score | Description | Malignancy Risk |
|---|---|---|
| 0 | Incomplete | - |
| 1 | Normal ovary | ~0% |
| 2 | Almost certainly benign | <3% |
| 3 | Low risk | 3-<30% |
| 4 | Intermediate risk | 30-<75% |
| 5 | High risk | ≥75% |
Key MRI criteria used:
- Morphology (purely cystic, cystic with solid component, purely solid)
- T2 signal of solid component
- DWI / ADC restriction
- DCE perfusion: Time-Intensity Curve (TIC) pattern
- Papillary projections / mural nodules
- Peritoneal deposits, ascites, lymphadenopathy
APPENDIX IV: IOTA SIMPLE RULES (Reference)
Malignant features (M-features):
| Code | Feature |
|---|---|
| M1 | Irregular solid tumour |
| M2 | Ascites |
| M3 | ≥4 papillary structures |
| M4 | Irregular multilocular-solid tumour ≥10 cm |
| M5 | Very high vascularity (score 4) |
Benign features (B-features):
| Code | Feature |
|---|---|
| B1 | Unilocular |
| B2 | Solid components <7 mm |
| B3 | Acoustic shadowing |
| B4 | Smooth multilocular, <10 cm |
| B5 | No vascularity (score 1) |
Classification:
- If only B-features: Classify as Benign
- If only M-features: Classify as Malignant
- If both or neither: Inconclusive - refer for expert evaluation or MRI
Source: Timmerman D, et al. Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery. BMJ 2008.
APPENDIX V: WHO CLASSIFICATION OF OVARIAN TUMOURS (5th Edition, 2020) - Summary
Epithelial Tumours:
- Serous: Benign / Borderline / Malignant (Low-grade / High-grade)
- Mucinous: Benign / Borderline / Malignant
- Endometrioid: Benign / Borderline / Malignant
- Clear cell: Benign / Borderline / Malignant
- Brenner / Transitional cell: Benign / Borderline / Malignant
- Seromucinous: Benign / Borderline / Malignant
- Undifferentiated / Dedifferentiated
Sex Cord-Stromal Tumours:
- Granulosa cell tumour (Adult / Juvenile)
- Sertoli-Leydig cell tumour
- Fibroma / Fibrothecoma / Thecoma
Germ Cell Tumours:
- Mature teratoma (Dermoid cyst)
- Immature teratoma
- Dysgerminoma
- Yolk sac tumour
- Mixed germ cell tumour
Metastatic Tumours:
- Krukenberg tumour
- Secondary from colorectal, gastric, breast, endometrial primaries
APPENDIX VI: INFORMED CONSENT FORM
[In English - to be translated into regional language as required by institution]
PATIENT INFORMATION SHEET
Title of Study: Role of Ultrasound and Cross-Sectional Imaging (CT and MRI) in the Characterization of Ovarian Neoplasms: A Prospective Diagnostic Accuracy Study
Principal Investigator: [Name, Designation, Department]
Institution: [Name of Institution]
Introduction:
You are being invited to participate in a research study. Before you decide to take part, it is important that you understand why the research is being done and what it involves. Please read the following information carefully and ask us if anything is unclear.
Purpose of the Study:
You have been referred for imaging of a mass in your pelvis / ovary. As part of this study, you will undergo ultrasound examination, a CT scan, and an MRI scan of your abdomen and pelvis. The purpose of this study is to compare the accuracy of these three imaging tests in identifying the nature (benign or cancerous) of the ovarian mass. The final diagnosis will be confirmed by the surgical specimen / tissue sample.
What Will Happen to Me?
- You will undergo a detailed ultrasound examination (including a transvaginal scan, if required), which takes approximately 20-30 minutes.
- You will undergo a CT scan of the abdomen and pelvis with an intravenous contrast injection.
- You will undergo an MRI of the pelvis with an intravenous gadolinium contrast injection.
- Blood samples (CA-125 and other tumour markers) will be collected as part of routine workup.
- No additional invasive procedure is being done solely for this study. Imaging is part of your standard clinical evaluation.
Risks:
- Ultrasound has no known risks.
- CT involves a small dose of radiation. Contrast dye may rarely cause allergic reactions; the team is equipped to manage these.
- MRI contrast (gadolinium) is generally safe. It should not be used in severe kidney disease.
- All procedures will be performed by experienced radiologists.
Benefits:
- Your participation will help improve the diagnosis of ovarian tumours in future patients.
- You will receive a comprehensive imaging evaluation as part of your care.
Confidentiality:
Your personal information will be kept confidential. Your name will not be used in any publication. Data will be stored in coded form.
Voluntary Participation:
Participation is entirely voluntary. You may withdraw at any time without affecting your medical care.
Contact:
For any queries, please contact: [PI Name, Phone, Email]
Ethics Committee: [IEC Name, Contact]
CONSENT FORM
I, ____________________________________________, aged ________ years,
having read / been explained the above information in a language I understand,
hereby voluntarily consent to participate in the above study.
I understand that I may withdraw at any time without affecting my care.
Signature / Thumb impression of Patient: _________________ Date: ___________
Signature of Witness: _________________ Date: ___________
Signature of Investigator: _________________ Date: ___________
APPENDIX VII: ETHICAL CLEARANCE CERTIFICATE
(To be obtained from Institutional Ethics Committee - IEC)
[Placeholder - attach the original IEC approval letter here]
Required information to be mentioned:
- IEC Registration No. (ECR/XXXXX/Inst/XX/20XX) as per CDSCO/ICMR guidelines
- Protocol No.:
- Date of approval:
- Title of the study (exact):
- Principal Investigator name and designation:
- Duration of study approved:
- Any conditions / recommendations by the committee:
Note: Ethical approval must be obtained from the IEC before enrollment of the first patient. The certificate must bear the stamp, signature of the IEC chairperson, and date.
APPENDIX VIII: MASTER CHART
(To be filled prospectively for each enrolled patient)
| S.No | Reg No. | Age | Menopausal Status | CA-125 | USG Diagnosis | O-RADS US | CT Diagnosis | MRI Diagnosis | O-RADS MRI | Histopathology | Concordance (USG) | Concordance (CT) | Concordance (MRI) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | |||||||||||||
| 2 | |||||||||||||
| ... |
APPENDIX IX: KEY TO ABBREVIATIONS
| Abbreviation | Full Form |
|---|---|
| ACR | American College of Radiology |
| ADC | Apparent Diffusion Coefficient |
| ADNEX | Assessment of Different NEoplasias in the adneXa |
| AFP | Alpha-Fetoprotein |
| AUC | Area Under the ROC Curve |
| BSO | Bilateral Salpingo-Oophorectomy |
| CA-125 | Cancer Antigen 125 |
| CE-CT | Contrast-Enhanced Computed Tomography |
| CEA | Carcinoembryonic Antigen |
| CT | Computed Tomography |
| DCE | Dynamic Contrast Enhancement |
| DWI | Diffusion-Weighted Imaging |
| FIGO | Federation of Gynecology and Obstetrics |
| GI-RADS | Gynecologic Imaging Reporting and Data System |
| HPE | Histopathological Examination |
| IEC | Institutional Ethics Committee |
| IOTA | International Ovarian Tumour Analysis |
| LDH | Lactate Dehydrogenase |
| LMP | Last Menstrual Period |
| MRI | Magnetic Resonance Imaging |
| NPV | Negative Predictive Value |
| O-RADS | Ovarian-Adnexal Reporting and Data System |
| PI | Pulsatility Index |
| PPV | Positive Predictive Value |
| RI | Resistive Index |
| RMI | Risk of Malignancy Index |
| ROC | Receiver Operating Characteristic |
| TAH | Total Abdominal Hysterectomy |
| TIC | Time-Intensity Curve |
| TVS | Transvaginal Sonography |
| USG | Ultrasonography |
| WHO | World Health Organization |
APPENDIX X: STATISTICAL ANALYSIS PLAN (Brief)
The following statistical measures will be computed for each modality (USG, CT, MRI) against the histopathological gold standard:
- Sensitivity = TP / (TP + FN) x 100
- Specificity = TN / (TN + FP) x 100
- Positive Predictive Value (PPV) = TP / (TP + FP) x 100
- Negative Predictive Value (NPV) = TN / (TN + FN) x 100
- Diagnostic Accuracy = (TP + TN) / (TP + TN + FP + FN) x 100
- ROC Curve Analysis with Area Under the Curve (AUC) for comparison of modalities
- Kappa coefficient for inter-rater agreement
- McNemar's test for paired comparison of sensitivity/specificity between modalities
- Chi-square test for categorical variables
- Mann-Whitney U test for continuous non-parametric data (e.g., ADC values)
Software to be used: SPSS v26.0 (IBM) / MedCalc / STATA
Level of significance: p < 0.05 (two-tailed)
Notes on Usage:
- Appendix I (Proforma) and Appendix VI (Consent) must be submitted in both English and the regional language of your institution.
- Appendix VII (IEC Certificate) is submitted as a scanned copy of the original.
- The O-RADS US (Appendix II) and O-RADS MRI (Appendix III) scoring systems are from the ACR 2020 consensus guidelines, which are now the international standard adopted in prospective diagnostic accuracy studies.
- The IOTA Simple Rules (Appendix IV) remain a validated comparator system widely used in Indian tertiary centres and should be applied alongside O-RADS for a stronger synopsis.
- The IOTA ADNEX model (IOTA Phase 6 validation, AJOG 2025) is the current external validation benchmark for ultrasound-based risk stratification and may be cited in your review of literature.
give me in concise form and give only CASE RECORD PROFORMA
CASE RECORD PROFORMA
Study: Role of Ultrasound, CT and MRI in Characterization of Ovarian Neoplasms
SECTION A: PATIENT DETAILS
| Serial No. | |
| Hospital No. | |
| Name (Initials) | |
| Age (years) | |
| Date of Imaging |
SECTION B: CLINICAL HISTORY
- Presenting complaint: _______________
- Duration: _______________
- Menopausal status: Pre / Peri / Post-menopausal
- LMP: _______________ Parity: G__ P__ L__ A__
- Previous pelvic surgery: Yes / No
- Family H/O ovarian / breast / colorectal cancer: Yes / No
Tumour Markers:
| Marker | Value |
|---|---|
| CA-125 (U/mL) | |
| CEA | |
| AFP | |
| Beta-hCG | |
| LDH |
SECTION C: ULTRASOUND FINDINGS (TVS + TAS)
Lesion Characteristics:
| Parameter | Finding |
|---|---|
| Side | Right / Left / Bilateral |
| Morphology | Unilocular / Multilocular / Solid / Mixed |
| Size (cm) | |
| Wall | Thin (<3 mm) / Thick (≥3 mm) |
| Septa | Absent / Thin / Thick |
| Papillary projections | Absent / Present (No.: ___) |
| Internal echogenicity | Anechoic / Low / Ground-glass / Mixed / Hyperechoic |
| Acoustic shadowing | Present / Absent |
| Ascites | None / Mild / Moderate / Massive |
| Peritoneal deposits | Absent / Present |
Colour Doppler:
| Parameter | Value |
|---|---|
| Vascularity | Absent / Peripheral / Central / Both |
| RI | |
| PI |
IOTA Simple Rules:
- B-features present (B1/B2/B3/B4/B5): _______________
- M-features present (M1/M2/M3/M4/M5): _______________
- Result: Benign / Malignant / Inconclusive
O-RADS US Score (0-5): _______ Impression: Benign / Borderline / Malignant
SECTION D: CECT ABDOMEN & PELVIS FINDINGS
| Parameter | Finding |
|---|---|
| Size (cm) | |
| Morphology | Cystic / Solid / Mixed |
| Pre-contrast density (HU) | |
| Post-contrast enhancement | None / Mild / Moderate / Marked |
| Fat component | Present / Absent |
| Calcification | Present / Absent |
| Septae / Mural nodules | Absent / Present |
| Peritoneal deposits | Absent / Present |
| Ascites | Absent / Present |
| Lymphadenopathy | Absent / Present (Station: ___) |
| Distant metastasis | Absent / Present (Site: ___) |
CT Impression: Benign / Borderline / Malignant
SECTION E: MRI PELVIS FINDINGS (1.5T / 3T)
| Parameter | Finding |
|---|---|
| Size (cm) | |
| T1 signal | Hypointense / Isointense / Hyperintense / Fat signal |
| T2 signal | Dark / Intermediate / Bright |
| T2 dark spot / shading | Present / Absent |
| DWI restriction | Present / Absent |
| ADC value (×10⁻³ mm²/s) | |
| DCE-TIC pattern | Type I (progressive) / Type II (plateau) / Type III (washout) |
| Papillary projections / Mural nodules | Absent / Present |
| Peritoneal deposits / Ascites | Absent / Present |
| Lymphadenopathy | Absent / Present |
O-RADS MRI Score (0-5): _______ Impression: Benign / Borderline / Malignant
SECTION F: HISTOPATHOLOGY (Reference Standard)
| Surgical procedure | Cystectomy / Oophorectomy / TAH+BSO / Biopsy |
| WHO Diagnosis | |
| Nature | Benign / Borderline / Malignant |
| FIGO Stage (if malignant) |
SECTION G: CONCORDANCE
| Modality | Correct Diagnosis | Incorrect |
|---|---|---|
| USG | Yes / No | |
| CT | Yes / No | |
| MRI | Yes / No |
Investigator Signature: _________________ Date: _________
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