Ultrasound Imaging for Endometrial Cancer

Recruiting at 6 trial locations

Overseen By Mark Burgess, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Chemotherapy, Hormonal therapy

Disqualifiers: Prior malignancy, Pelvic radiotherapy, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Varies

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of ultrasound imaging to help doctors understand the effects of a common cancer treatment on vaginal tissue. The treatment, known as IVRT (a form of radiation therapy), is used for endometrial cancer but can cause side effects like dryness or soreness. Researchers aim to determine how well the ultrasound tracks these changes and whether patients find the imaging process comfortable. This trial suits those who have had surgery for endometrial cancer, have no other major health issues, and are ready to start radiation therapy soon. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving chemotherapy or hormonal therapy.

What prior data suggests that multiparametric ultrasound imaging is safe for evaluating vaginal tissue?

Research shows that multiparametric ultrasound (mpUS) imaging is generally easy for people to handle. Studies have found that ultrasound imaging is safe and doesn't involve any cutting or surgery, with no reports of serious side effects from mpUS itself.

This method lets doctors examine the body using sound waves, avoiding radiation. This makes it safer than imaging methods like X-rays or CT scans. Since ultrasound is already widely used for other medical conditions, it has a strong safety record.

Overall, current evidence supports that mpUS imaging is safe for participants, with no known harmful side effects from the procedure itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about multiparametric ultrasound imaging (mpUS) for endometrial cancer because it offers a non-invasive way to visualize the tumor and its response to treatment. Unlike traditional imaging techniques, mpUS provides detailed information about tissue characteristics and blood flow, which can help tailor and monitor treatment more effectively. This approach has the potential to enhance precision in treatment planning and follow-up, making it a promising tool in the fight against endometrial cancer.

What evidence suggests that multiparametric ultrasound imaging is effective for evaluating vaginal tissue in endometrial cancer patients?

Research shows that multiparametric ultrasound (mpUS) imaging is promising for checking changes in vaginal tissue. Studies have found that these ultrasound techniques effectively detect various conditions, with success rates between 76% and 96%. In this trial, all participants will receive mpUS imaging alongside standard intravaginal brachytherapy (IVRT) at specified intervals. This approach allows mpUS to effectively spot changes, crucial for monitoring tissue after treatments like IVRT. Although its ability to rule out non-issues can vary, mpUS still provides a detailed view of tissue changes. This detailed imaging could help doctors better understand and possibly prevent side effects like vaginal toxicity. ^{1 2 4 6 7}

Who Is on the Research Team?

Kaled Alektiar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This study is for individuals with endometrial cancer who are undergoing or have completed Intravaginal Radiation Therapy (IVRT). Participants should be able to undergo multiparametric ultrasound imaging and must not have conditions that interfere with the procedure.

Inclusion Criteria

I had surgery for my condition that included removing my uterus, both ovaries, fallopian tubes, and checking the lymph nodes in my pelvis.

I have been diagnosed with a specific type of endometrial cancer.

I can start radiotherapy within 12 weeks after my surgery.

Exclusion Criteria

Concurrent psychiatric or medical condition or disease which, per investigator judgement, would make them unsuitable candidates for study enrollment

I do not have a serious urinary infection needing antibiotics.

I am currently on chemotherapy or hormonal therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard intravaginal brachytherapy (IVRT) and undergo multiparametric ultrasound (mpUS) imaging right before and immediately after the last IVRT treatment

Varies

2 visits (in-person)

Follow-up

Participants are monitored with multiparametric ultrasound (mpUS) imaging at 3, 6, and 12 months after IVRT to assess vaginal tissue response

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multiparametric Ultrasound Imaging

Trial Overview

The trial is testing how well a type of advanced ultrasound, called multiparametric ultrasound imaging (mpUS), can assess vaginal tissue affected by radiation therapy used in treating endometrial cancer. The goal is to monitor for potential damage from treatment.

How Is the Trial Designed?

Group I: Multiparametric Ultrasound Imaging (mpUS) Experimental Treatment 2 Interventions

All participants in this study will receive standard intravaginal brachytherapy (IVRT) and multiparametric ultrasound (mpUS) imaging right before IVRT, right after the last IVRT, and at 3, 6 and 12 months after IVRT.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07318415

A Study of Multiparametric Ultrasound Imaging (mpUS) for ...

The researchers are doing this study to see how well multiparametric ultrasound (mpUS) imaging can evaluate vaginal tissue before and after IVRT ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12476809/

Advances in ultrasound-based imaging for diagnosis of ...

TVUS exhibited high sensitivity (76%–96%) for initial screening but showed moderate to variable specificity (61%–86%), particularly in ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352047724000145

Evaluation of multi-parameter MRI in preoperative staging ...

This study explores the application value of multi-parameter MRI in diagnosing and staging endometrial cancer.

4.

frontiersin.org

frontiersin.org/journals/oncology-reviews/articles/10.3389/or.2025.1446850/full

Ultrasound in endometrial cancer: evaluating the impact of ...

This review aims to summarize the progressive role of clinical implementation of pelvic ultrasonography in the locoregional staging of endometrial carcinoma.

5.

academic.oup.com

academic.oup.com/bjr/article-abstract/94/1119/20201195/7451693

Multiparametric transvaginal ultrasound in the diagnosis of ...

Among 152 females with ET ≥ 4 mm at first line TVUS, 88 (57.9%) patients had endometrial cancer on final pathologic analysis. Real-time ultrasound criteria (ET ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-of-multiparametric-ultrasound-imaging-mpus-for-people-with-endometrial-cancer

A Study of Multiparametric Ultrasound Imaging (mpUS) for ...

The researchers are doing this study to see how well multiparametric ultrasound (mpUS) imaging can evaluate vaginal tissue before and after ...

7.

clin.larvol.com

clin.larvol.com/trial-detail/NCT07318415

A Study of Multiparametric Ultrasound Imaging (mpUS) for ...

A Study of Multiparametric Ultrasound Imaging (mpUS) for People With Endometrial Cancer. B-mode feasibility is defined as the ability to visualize/quantify ...