The ovaries, paired organs situated near the lateral pelvic wall, that exhibit a complex physiological architecture and are susceptible to a wide spectrum of pathological conditions, ranging from non-neoplastic to neoplastic changes. Ovarian tumors constitute a significant portion of female neoplasms, with functional and benign cysts being the most commonly observed lesions. It primarily affects women over the age of 30 and is frequently diagnosed at an advanced stage due to its asymptomatic nature in early stages, contributing to a poor prognosis. Globally, the five-year survival rate for ovarian cancer remains low, typically ranging between 20% and 30%. India bears a significant portion of this burden, with a reported five-year survival rate of approximately 29%^[1].Given the high mortality associated with ovarian cancer, early detection and accurate risk stratification are critical for optimizing treatment outcomes. Distinguishing non-neoplastic from neoplastic ovarian lesions remains a diagnostic challenge, as even benign cystic lesions can present as pelvic masses with abnormal clinical features^[2].

Timely diagnosis and intervention depend on the application of standardised imaging techniques, risk assessment models, and systematic screening programs. The predominant method for evaluating ovarian lesions at the initial stage is still ultrasound, as opposed to other imaging modalities like computed tomography (CT) and magnetic resonance imaging (MRI), because of its affordability, ease of use, and capacity for real-time evaluation (ACR O-RADS Committee, 2020)^[3]. Although CT and MRI offer useful extra information in circumstances that are unclear or complex,, O-RADS, a first-line categorisation method based on ultrasound, increases diagnostic precision and minimises needless procedures. By combining Doppler ultrasound and morphological criteria.

The application of O-RADS in routine gynaecologic imaging has improved ultrasound's ability to diagnose and treat ovarian cancer by offering a dependable framework for enhanced patient care and standardised reporting.This study aims to To evaluate the effectiveness of the Ovarian-Adnexal Reporting and Data System (O-RADS) in classifying ovarian masses using standardized sonographic descriptors.

This hospital-based, prospective observational study was conducted over a period of one year in the Department of Radio Diagnosis at Mahatma Gandhi Memorial Medical College and M.Y. Hospital, Indore, Madhya Pradesh, India, following approval from the institutional ethics committee. The study population comprised patients who were clinically suspected of having ovarian masses and were referred by the Department of Obstetrics and Gynaecology to the Department of Radio Diagnosis for pelvic ultrasound evaluation. A total of 80 patients meeting the inclusion criteria were enrolled for the study.

INCLUSION CRITERIA

1. Patients with a clinical suspicion of an ovarian mass.
2. Patients aged 18 years or older with a clinical suspicion of an ovarian mass.

EXCLUSION CRITERIA

1. Patients younger than 18 years.
2. Patients who had previously undergone oophorectomy.
3. Patients with a prior known malignancy. Pregnant patients.

STUDY PROTOCOL- Patients were selected for the study based on predefined inclusion and exclusion criteria. Informed written consent was obtained from all participants after explaining the study details and potential risks to them and/or their attendants. A detailed history, physical examination findings, and radiological investigations were documented in a structured format. Each patient underwent transabdominal and transvaginal ultrasound evaluations, and based on the ultrasound findings, the O-RADS classification was assigned for risk stratification. All collected data were organized and tabulated using Microsoft Excel and subsequently analyzed using open-source statistical software (SPSS).

STATISTICAL ANALYSIS

Data from all the visits were tabulated in Microsoft Excel sheet for analysis.Further depiction of data was done in the form of tables and charts. SPSS was used to analyse the data. Results was correlated and compared with histopathological analysis wherever possible.

Table 1: Distribution of patients according to ORADS grading on the basis of grey scale

Among 80 patients, 32 (40%) were in the ORADS 2 category, followed by ORADS 3 18 (22.5%) both suggesting likely benign findings. Fewer patients were in higher-risk groups—ORADS 4 (15%) and ORADS 5 (8.8%)—which may suggest malignant features.

Table 2: Distribution of patients according to ORADS colour score

In our study, after using colour score grading, 40 lesions (50%) showed no colour flow (colour score 1), 26 lesions (32.5%) were with minimal colour flow (colour score 2), 9 lesions (11.5%) demonstrated moderate colour flow (colour score 3), and 5 lesions (6.2%) showed severe colour flow (colour score 4)

Table 3:  Patients distribution based on risk stratification of ovarian lesion

On interpretation of ovarian lesions based on B-mode morphology alone, 61 out of 80 [76%] were benign and 19 out of 80 [23%] malignant.

Table 4: Distribution of patients on the basis of histopathological examination

Out of the total80 patients, histopathological examination was conducted on 36 patients. The remaining lesions resolved or decreased in size with subsequent follow-up. On histopathological examination of the 36 patients, 23 lesions (64%) were found to be benign, while 13 lesions (36%) were malignant.

Table 5 -Statistical comparison of interpretation by USG and histopathological examination / Follow-up

Ultrasound (B-mode) demonstrates high sensitivity (92.86%) in detecting malignant cases, accurately identifying most true positives. However, its specificity is lower (72.73%), leading to some benign cases being incorrectly labeled as malignant. Of the 19 cases identified as malignant by ultrasound, only 12 were confirmed by histopathology, while 7 were false positives. One malignant case was missed. These results highlight ultrasound’s strong detection capability but also the need for confirmatory tests to ensure accurate diagnosis.

Table 6: Statistical comparison of interpretation by USG with colour doppler flow and histopathological Examination / Follow-up

Ultrasound with color Doppler shows improved accuracy compared to B-mode alone. It has a higher specificity of 95.68% i.e. fewer false positives,and a good sensitivity of 84.62%. Out of 12 cases marked as malignant, 11 were confirmed, and only one was a false positive. It also correctly identified 22 out of 23 benign cases. These results suggest that adding color Doppler to ultrasound improves the ability to accurately differentiate between benign and malignant ovarian masses.

Case 1: A female aged 35 years with complaints of pelvic pain

6. a) USG revealed a 6.6*6.4cm sized cystic lesion with smooth inner wall and echogenic content b) Colour Doppler exam showed no vascularity (CS1).

 O-RADS 2 (Benign cystic lesion).

Histopathology: Dermoid cyst

Case 2: A young female aged 26 years complaining of abdominal pain

 (a,c) USG exam. revealed a 17*10 cm sized multilocular cystic lesion with smooth inner wall, thick septa and internal homogenous contents.

(b,d) Colour Doppler exam showed mild vascularity (CS2).

 O-RADS 4.

Histopathology: Mucinous cystadenoma ova

Case 3: A young female aged 19 years with irregular vaginal bleeding

Figure(a)

(a,b) USG exam showed a well demarcated solid lesion with smooth outlines.

1. c) Colour Doppler exam. showed minimal vascularity (C2).

ORADS 3 (Benign ovarian cystic lesion).

 Histopathology: Juvenile granulosa cell tumor.

In our study, the majority of ovarian lesions were categorized as ORADS 2 (40%) and ORADS 3 (22.5%) on grey-scale ultrasound, indicating a high likelihood of benignity. This aligns with the findings of Timmerman et al.,^[2] who reported that most adnexal masses fall within the benign ORADS 2–3 categories in screening populations, supporting the utility of grey-scale morphology in initial risk stratification. Higher-risk categories such as ORADS 4 (15%) and ORADS 5 (8.8%), suggestive of malignancy, were relatively less common.

The use of colour Doppler scoring provided further diagnostic insight. A substantial proportion of lesions (50%) showed no colour flow (score 1), while 32.5% demonstrated minimal flow (score 2). Only 11.2% and 6.2% of cases showed moderate and marked vascularity (scores 3 and 4, respectively), which are often associated with increased malignancy risk. These findings are in concordance with those of Valentin et al.,^[4] who demonstrated that increased vascularity within adnexal lesions correlates strongly with malignant potential.

Based on B-mode ultrasound morphology alone, 76.2% of cases were considered benign, and 23.7% were classified as malignant. However, histopathological analysis of 36 operated or biopsied cases revealed that 63.9% of the lesions were benign and 36.1% were malignant. This discrepancy highlights the limitations of relying solely on morphology and emphasizes the need for adjunctive tools such as Doppler.

When ultrasound findings were compared with histopathological results, B-mode alone demonstrated a high sensitivity of 92.86%, successfully identifying most malignant lesions. However, the specificity was 72.73%, reflecting a higher rate of false positives benign lesions were incorrectly labeled as malignant, and one malignant lesion was missed. This pattern is consistent with the study by Kinkel et al.,^[5] which showed that while B-mode ultrasound is highly sensitive, it often lacks the specificity needed to rule out malignancy in complex or atypical lesions.

The addition of colour Doppler flow assessment significantly improved diagnostic accuracy. With specificity increasing to 95.68% and a still favorable sensitivity of 84.62%, colour Doppler was particularly effective in reducing false positives only one benign lesion was misclassified as malignant. Moreover, 22 out of 23 benign lesions were correctly identified. These results are in agreement with the findings of Fleischer et al.^[6] and Alcázar et al.,^[7] who have both emphasized that incorporating Doppler parameters enhances the ability to differentiate between benign and malignant ovarian tumors, particularly by assessing neovascularization and vascular resistance patterns.

In conclusion, our findings reinforce the value of combining grey-scale ultrasound with colour Doppler in the evaluation of adnexal masses. While grey-scale imaging provides a useful morphological framework, the addition of Doppler flow significantly improves specificity and overall diagnostic performance, thereby reducing unnecessary interventions and improving patient triage.

This study underscores the crucial role of ultrasound, especially when combined with color Doppler and O-RADS, in evaluating ovarian masses.Ultrasound findings aligned well with histopathology, confirming high diagnostic accuracy. The combined approach offers a sensitive, specific, and cost-effective tool for initial risk stratification.

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