This chapter should be cited as follows:
Valentin L, Glob Libr Women's Med
ISSN: 1756-2228; DOI 10.3843/GLOWM.419673

The Continuous Textbook of Women’s Medicine Series – Gynecology Module

Volume 10

Ultrasound in gynecology

Volume Editors: Professor Antonia Testa, Agostino Gemelli University Hospital, Rome, Italy
Professor Simona Maria Fragomeni, Agostino Gemelli University Hospital, Rome, Italy

Chapter

How to Discriminate Between Benign and Malignant Adnexal Masses using Ultrasound

First published: September 2025

AUTHOR(S)

Lil Valentin

Senior Professor, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden

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INTRODUCTION

Ultrasound has become the method of choice to diagnose adnexal pathology. By combining clinical and ultrasound information, an experienced ultrasound examiner using pattern recognition can discriminate effectively between benign and malignant adnexal masses and often also provide a correct specific diagnosis of a benign mass, for example, dermoid cyst, endometrioma, mucinous cystadenoma, cystadenofibroma, fibroma or hydrosalpinx¹^,²^,³^,⁴^,⁵^,⁶ (see also the chapter on benign ovarian tumors in this volume (Role of Ultrasound in the Diagnosis of Benign Ovarian Masses | Article | GLOWM). Specific types of malignancy, for example, different types of borderline tumor and invasive malignancy, can also be recognized by an expert ultrasound examiner.⁷ From a clinical perspective, the most important objective is to distinguish malignant from benign adnexal masses. To achieve the best possible outcome, malignant masses should be treated in oncology centers,⁸ while benign masses can be managed expectantly with clinical and ultrasound follow-up, or be removed by surgery in a local hospital.⁹^,¹⁰

To help less experienced ultrasound examiners differentiate between benign and malignant adnexal masses, scoring systems and risk prediction models have been developed.¹¹^,¹²^,¹³^,¹⁴^,¹⁵^,¹⁶^,¹⁷^,¹⁸^,¹⁹^,²⁰ One of the oldest models is the risk of malignancy index (RMI),¹⁵ which is incorporated into guidelines on management of ovarian masses in some countries, for example in the UK.²¹ The most extensively validated methods for discrimination between benign and malignant adnexal masses are those developed by the International Ovarian Tumor Analysis (IOTA) group. The IOTA group has developed simple ultrasound rules that help distinguish malignant from benign adnexal masses,¹⁸^,²²^,²³ as well as mathematical models that calculate the risk that an adnexal mass is malignant.¹⁷^,²⁰^,²⁴^,²⁵^,²⁶^,²⁷ The IOTA methods have been externally validated on thousands of patients and have shown excellent ability to discriminate between benign and malignant adnexal masses.²¹^,²⁶^,²⁷^,²⁸^,²⁹^,³⁰^,³¹^,³²^,³³ However, for the IOTA methods to work, it is important that the IOTA examination technique, measurement methods and terminology are used.³⁴ These are consistently applied in all IOTA studies and are now being introduced into clinical practice worldwide. For details, please consult the freely accessible IOTA terms-and-definitions article,³⁴ which is an integral part of this chapter. An updated version of the terms-and-definitions article is currently in preparation and will also be freely accessible. Online IOTA certification courses are offered on the IOTA website (https://iotaplus.org/en). The following is a description of the most commonly used IOTA methods.

IOTA METHODS THAT DO NOT REQUIRE ACCESS TO COMPUTER SOFTWARE

IOTA ‘benign descriptors’

There are four benign descriptors,²⁷ examples of which are shown in Figure 1. If a benign descriptor applies to a mass, that mass is almost certainly benign, the risk of malignancy being estimated to be less than 1%.²⁷^,³³ Approximately 40% of all adnexal masses examined in hospitals and approximately 80% of all adnexal masses detected in a screening population fulfill the criterion of a benign descriptor.²⁷^,³³ Expectant management with clinical and ultrasound follow-up is an alternative to surgery for masses to which a benign descriptor applies.¹⁰

Benign descriptor 1 Unilocular cyst with ground glass echogenicity and largest diameter <10 cm in a premenopausal woman (presumed diagnosis endometrioma)
Benign descriptor 2 Unilocular cyst with mixed echogenicity and shadowing and largest diameter <10 cm in a premenopausal woman (presumed diagnosis dermoid cyst)
Benign descriptor 3 Unilocular cyst with regular walls, anechoic cyst fluid and largest diameter <10 cm (presumed diagnosis simple cyst or cystadenoma)
Benign descriptor 4 All other unilocular cysts with regular walls and largest diameter <10 cm (classified as benign)

The International Ovarian Tumor Analysis (IOTA) ‘benign descriptors’. If a benign descriptor applies to an adnexal mass, the risk of malignancy is estimated to be <1%, and the mass can be managed as being almost certainly benign, i.e. conservative management with clinical and ultrasound follow-up is appropriate if the patient has no symptoms or clinical indication for surgery.

IOTA ‘simple rules'

Using the simple rules, there are five benign ultrasound features and five malignant ultrasound features¹⁸^,²³ (Figure 2). If only benign ultrasound features apply to a mass, the mass is classified as benign. If only malignant ultrasound features apply, the mass is classified as malignant. If both benign and malignant ultrasound features apply, or if none of the 10 features applies, the mass cannot be classified by the simple rules (inconclusive result). When the simple rules were prospectively validated, they were applicable to 76–89% of all adnexal masses.²⁹^,³⁰

The International Ovarian Tumor Analysis (IOTA) ‘simple rules’: (a) benign ultrasound features; (b) malignant ultrasound features. If only benign ultrasound features apply, the mass can be safely classified as benign. If only malignant ultrasound features apply the risk of malignancy is high and the mass should be classified as malignant. If none of the features applies, or if both benign and malignant features apply, the mass cannot be classified using simple rules and the results are considered inconclusive. Inconclusive results indicate a relatively high risk of malignancy (27.5–48.7%).²⁰

When an inconclusive result is obtained on application of the simple rules, one option is to refer the patient to a highly experienced ultrasound examiner, who will use pattern recognition to classify the mass. Another solution is to classify inconclusive results as malignant. The risk of malignancy in case of an inconclusive result is estimated to be in the range of 27.5–48.7%.²⁰

The simple rules have excellent ability to discriminate between benign and malignant adnexal masses. In a meta-analysis of six studies including 3568 adnexal masses, Nunes et al. found the sensitivity of the simple rules, when applicable, to be 93% and the specificity to be 95%.²⁹ This means that the simple rules provided a virtually conclusive diagnosis of benignity or malignancy. The ability of the IOTA simple rules to discriminate between benign and malignant adnexal masses, when inconclusive results are classified as malignant, has been estimated in three meta-analyses.³⁰^,³¹^,³² Using this strategy, the likelihood that a mass classified as benign by the simple rules is actually malignant is very low, while the likelihood that a mass classified as malignant is truly malignant is only moderately increased (sensitivity, 93–94%; specificity, 76–81%; positive likelihood ratio, 3.9–4.9; and negative likelihood ratio, 0.08–0.09.³⁰^,³¹^,³²

IOTA METHODS THAT REQUIRE ACCESS TO COMPUTER SOFTWARE

Assessment of Different NEoplasias in the adneXa (ADNEX) model

The IOTA group has created four mathematical models to calculate the risk of malignancy in adnexal masses: logistic regression model 1, logistic regression model 2, the Assessment of Different NEoplasias in the adneXa (ADNEX) model, and the Simple Rules Risk calculation model.¹⁷^,¹⁹^,²⁰ Of these, the ADNEX model is the most extensively validated.²⁸ ADNEX is a polynomial logistic regression model that categorizes ovarian tumors into five groups: benign, borderline, Stage-I primary invasive malignancy, Stage-II–IV primary invasive malignancy and secondary metastasis. The overall malignancy risk is derived by subtracting the probability of a benign tumor from 1. ADNEX includes nine predictor variables: three clinical variables and six ultrasound variables. The clinical variables are patient age (in years), serum CA 125 (IU/mL) (optional variable) and whether the ultrasound examination was carried out in an oncology center or in another type of center (yes or no). The ultrasound variables are the maximum diameter of the lesion as measured with calipers on the frozen ultrasound image (in mm), the proportion of solid tissue (value between 0 and 1) calculated as the maximum diameter of the largest solid component (in mm) divided by the maximum diameter of the lesion (in mm), the presence of more than 10 cyst locules (yes or no), the number of papillary projections (0, 1, 2, 3, 4, with 4 indicating more than three), the presence of acoustic shadows (yes or no) and the presence of ascites (yes or no). The ADNEX model is incorporated as a free app in many ultrasound machines. ‘Conformité Européenne’ (CE) marked ADNEX applications for the web and for mobile phones and tablets are likely to be available in Europe in the autumn of 2025 but will not be free. For those who want to create their own calculator (for example in an Excel file), the mathematical formula of the ADNEX model is provided at the end of this chapter.

ADNEX has been externally validated in 47 studies on 17 007 tumors in 27 countries and has shown excellent discriminative ability with an area under the receiver-operating-characteristics curve (AUC) of 0.93 and AUC ≥0.90 in all investigated subgroups²⁸ (an AUC of 1 indicates perfect discrimination). ADNEX is well calibrated, i.e. the calculated risk of malignancy agrees well with the observed prevalence of malignancy, albeit with heterogeneity between ultrasound centers.²⁶ ADNEX is also integrated in the Ovarian-Adnexal Reporting and Data System (O-RADS) proposed by the American College of Radiology³⁵^,³⁶ and is recommended in an international consensus statement on preoperative diagnosis of ovarian tumors.¹⁰ According to the consensus statement, the risk of malignancy calculated by ADNEX can be used to assign the patient to one of four risk groups (i.e. in one of the O-RADS risk groups 2, 3, 4 and 5) with a recommendation for management for each risk group.¹⁰ If the risk of malignancy is <1%, conservative management with clinical and ultrasound follow-up may be possible, if the risk is 1–<10%, the patient can be managed in a local hospital, but if the risk is ≥10%, the patient should be referred to a center for gynecological oncological surgery (Figure 3).

Flowchart of steps recommended to distinguish between benign and malignant tumors and to direct patients towards appropriate treatment pathway. Modified from Timmerman et al.¹⁰

IOTA two-step strategy

Instead of using the ADNEX model in all tumors, the IOTA group suggests a two-step strategy. This means that the benign descriptors are used as a first step, and if these do not apply, ADNEX is used.²⁷ If a benign descriptor applies, the risk of malignancy is very low and the mass can be managed as almost certainly benign, i.e. with clinical and ultrasound follow-up, or with surgery in a local hospital. If a benign descriptor does not apply, ADNEX is used to calculate the risk of malignancy, and the calculated risk of malignancy is used to assign the patient to one of the four O-RADS risk groups. This follows the algorithm shown in Figure 3. The two-step strategy is well suited to use in clinical practice.

The simple rules can also be used in a two-step strategy. The benign descriptors are used as a first step and, if a benign descriptor does not apply, the simple rules are used to estimate the likelihood that the tumor is malignant. If only benign ultrasound features of the simple rules apply, the risk of malignancy is low. The remaining masses can be classified as malignant. This two-step strategy facilitates the use of the simple rules in clinical practice.

Mathematical formula for ADNEX

ADNEX is a polynomial logistic regression model that categorizes ovarian tumors into five groups: benign, borderline, Stage-I primary invasive malignancy, Stage-II–IV primary invasive malignancy and secondary metastasis. The overall malignancy risk is derived by subtracting the probability of a benign tumor from 1.²⁸

The clinical variables are patient age in years, serum CA 125 IU/mL (optional variable) and whether the ultrasound examination was carried out in an oncology center or in another type of center (onc 1 = yes or 0 = no). The ultrasound variables are the maximum diameter of the lesion as measured with calipers on the frozen ultrasound image in mm (mdl), the proportion of solid tissue (value between 0 and 1) calculated as the maximum diameter of the largest solid component in mm divided by the maximum diameter of the lesion in mm (pst), the presence of more than 10 cyst locules (tcl 1 = yes or 0 = no), the number of papillary projections (nps 0, 1, 2, 3, 4, with 4 indicating more than three), the presence of acoustic shadows (sha 1 = yes or 0 = no) and the presence of ascites (asc 1 = yes or 0 = no).

Formula for ADNEX:

Where, when including CA 125,

And, when not including CA 125,

PRACTICE RECOMMENDATIONS

When examining an adnexal mass with ultrasound, the International Ovarian Tumor Analysis (IOTA) standardized examination technique and measurement methods should be used
When describing the ultrasound features of an adnexal mass, the IOTA terminology should be used
If an IOTA ‘benign descriptor’ applies to an adnexal mass, the mass is highly likely to be benign, and conservative management with clinical and ultrasound follow-up is possible
If only benign features of the IOTA ‘simple rules’ apply to an adnexal mass, the mass is highly likely to be benign and management in a local hospital is possible
If only malignant features of the IOTA simple rules apply to an adnexal mass, the mass is highly likely to malignant and should be managed in a referral center for gynecological oncology
If the IOTA simple rules yield an inconclusive result, the patient could be referred to a highly experienced ultrasound examiner, who will use pattern recognition to classify the mass, alternatively the mass could be classified as malignant and managed as such.
The risk of malignancy for an adnexal mass can be calculated using an application for the Assessment of Different NEoplasias in the adneXa (ADNEX) model, and the calculated risk can be used to assign the tumor to one of the four Ovarian-Adnexal Reporting and Data System (O-RADS) risk groups (risk <1%, risk 1–<10%, 10–<50% and ≥50%). An international consensus statement suggests how to manage each risk group.¹⁰

CONFLICTS OF INTEREST

The author(s) of this chapter declare that they have no interests that conflict with the contents of the chapter.

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