Advanced Imaging for Ovarian Cancer

Overseen By Ines Nikolovski, MBBS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Renal impairment, Other ovarian cancer, Endometrial cancer, Prior abdominal chemotherapy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve treatment for high-grade serous ovarian carcinoma (HGSOC) by using advanced imaging and tests on blood and tissue samples. Researchers will combine PET/MRI scans with genetic and immune tests to create a detailed cancer profile. The goal is to predict tumor response to treatment and better personalize therapies. This trial may suit those diagnosed with advanced-stage HGSOC who have recently undergone a CT scan as part of their care. As an unphased study, this trial offers a unique opportunity to contribute to cutting-edge research that could lead to more personalized treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude patients who have received prior chemotherapy for any abdominal or pelvic tumor, except for adjuvant chemotherapy for breast cancer.

What prior data suggests that PET/MRI is safe for imaging ovarian cancer?

Research shows that PET/MRI scans are generally safe and well-tolerated by patients. Studies have found that MRI accurately diagnoses ovarian cancer, with a sensitivity of 91% and specificity of 85%. This means it effectively identifies the disease when present and confirms its absence when not.

Medical imaging often uses PET/MRI scans, which have not been linked to serious side effects. They provide detailed pictures of the body's interior, helping doctors see the structure of organs and tissues. No strong evidence suggests major safety concerns with using PET/MRI in this context.

Overall, participants can feel confident about the safety of this imaging method based on its established use in similar medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about advanced imaging techniques like PET/MRI for ovarian cancer because they offer a more detailed view of the cancer's progression and response to treatment. Unlike traditional imaging methods, PET/MRI combines metabolic and anatomical imaging, providing a comprehensive picture in a single scan. This could lead to more personalized treatment plans by accurately assessing how well the cancer is responding to chemotherapy before surgery. By fine-tuning treatment strategies, PET/MRI has the potential to improve outcomes for patients with ovarian cancer.

What evidence suggests that this imaging method is effective for profiling high-grade serous ovarian carcinoma?

Research has shown that [18F]FDG PET/MRI effectively diagnoses ovarian cancer, achieving an accuracy rate of 92.5%. This accuracy helps doctors better understand the cancer's stage and extent. In this trial, participants will undergo PET/MRI scans, which combine two imaging types to create a detailed body picture. This detailed view can help predict a tumor's response to treatment. In gynecologic cancers like ovarian cancer, PET and MRI serve as valuable tools for making treatment decisions. These imaging techniques enable doctors to create more personalized treatment plans for patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Viktoriya Paroder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced high-grade serous ovarian carcinoma (HGSOC). Participants must have had a CT scan at the study's institution, agree to tissue banking, and plan to undergo multi-region tissue collection. Pregnant women are excluded, as well as those unable to consent or undergo PET/MRI scans due to medical devices or conditions like claustrophobia.

Inclusion Criteria

Your blood sugar level should be no higher than 200 mg/dL.

I have agreed to donate my tissue for research and will undergo multiple tissue collections.

I have a CT scan of my abdomen, pelvis, and possibly chest in the hospital's system.

Exclusion Criteria

I have no other cancers except for non-melanoma skin cancer.

I have had chemotherapy for cancer in my abdomen, pelvis, or as a breast cancer treatment.

I don't have any large tumors in my pelvis that can be seen on a CT scan and sampled during surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Tissue Sampling

Participants undergo PET/MRI scans and multi-region tissue sampling before and after neoadjuvant chemotherapy or prior to primary debulking surgery

Up to 30 days before surgery

2 visits (in-person) for imaging

Data Analysis

Computers analyze combined imaging and genetic/immune system test results to develop a detailed tumor profile

Ongoing throughout the study

Follow-up

Participants are monitored for safety and effectiveness after imaging and tissue sampling

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Contrast enhanced CT
• PET/MRI

Trial Overview The trial aims to create a detailed profile of HGSOC by combining PET/MRI imaging with blood and tissue tests. This could lead to more personalized treatments by predicting tumor response better. Researchers will use computer analysis on imaging results alongside genetic and immune system tests from tumors.

How Is the Trial Designed?

Group I: Imaged prior to primary debulking surgery Experimental Treatment 2 Interventions

Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection. Concretely, in patients triaged to primary debulking surgery (PDS), PET/MRI will be obtained within 30 days preceding multi-region tissue collection at the time of PDS (already being done under IRB# 06-107).

Group II: Imaged pre/postneoadjuvant chemotherapy (NACT) Experimental Treatment 2 Interventions

In patients triaged to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS), PET/MRI will be obtained at two time points, i.e. first within 30 days preceding NACT/ multi-region laparoscopic tissue sampling (already being done under IRB# 06-107) and, second, any time after completion of NACT and before multi-region tissue collection at the time of interval debulking surgery (already being done under IRB# 06-107).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Integrated PET/contrast-enhanced CT demonstrated higher sensitivity (78.8%) and accuracy (84.8%) for detecting recurrent ovarian cancer compared to PET/non-contrast-enhanced CT (sensitivity 74.2%, accuracy 82.6%) and enhanced CT alone (sensitivity 60.6%, accuracy 72.7%).

The use of PET/contrast-enhanced CT resulted in a change of management for 39% of patients, indicating its significant impact on clinical decision-making for those suspected of having recurrent ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of integrated FDG-PET/contrast-enhanced CT in the diagnosis of recurrent ovarian cancer: comparison with integrated FDG-PET/non-contrast-enhanced CT and enhanced CT. Kitajima, K., Murakami, K., Yamasaki, E., et al.[2021]

Combining [(18)F]FDG-PET with CT significantly improves the detection of viable tumors in ovarian cancer patients after treatment, identifying 19 out of 23 lesions compared to 16 detected by CT alone.

The use of PET+CT results in higher sensitivity (82.60% vs. 69.56%) and negative predictive value (73.33% vs. 58.82%) for assessing residual tumors, making it a more reliable method for evaluating treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced ovarian carcinoma: usefulness of [(18)F]FDG-PET in combination with CT for lesion detection after primary treatment. Picchio, M., Sironi, S., Messa, C., et al.[2016]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39269504/

Comparing the diagnostic efficacy of [18F]FDG PET/CT and ... Conclusions: Our meta-analysis reveals that [18F]FDG PET/CT exhibits higher sensitivity while maintaining similar specificity compared to MRI ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7532239/

Diagnostic value of [18F]FDG PET/MRI for staging in ... Accuracy for the characterization of suspected ovarian cancer was significantly better for [18F]FDG PET/MRI (92.5%) [95% confidence interval (CI) 0.84–0.95] ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.230006

Added Value of FDG PET/MRI in Gynecologic Oncology FDG PET and MRI independently play a valuable role in the management of patients with gynecologic malignancies, particularly endometrial and cervical cancer.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633225001837

A Meta-analysis of 68Ga-FAPI PET in Assessment ... Conclusion. 68Ga-FAPI PET CT/MR displayed a high overall diagnostic effectiveness in OC. When evaluating metastatic peritoneal lesions of OC, ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.09.3522

MRI, CT, and PET/CT for Ovarian Cancer Detection and ... A meta-analysis comparing techniques for detection of recurrence determined that PET/CT (sensitivity, 91%; specificity, 88%) performed better than CT ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9327775/

The role of CT, PET-CT, and MRI in ovarian cancer - PMC A recent meta-analysis showed that MRI had a sensitivity of 91% and specificity of 85% for the diagnosis of ovarian cancer. This means that MRI outperforms CT ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03965481

PET/MR Versus CECT Scans in Imaging Patients With ... This trial is being done to see if PET/MR scans may help doctors locate ovarian cancer tumors, predict how well these tumors may be removed during surgery, and ...

8. mdpi.com mdpi.com/2072-6694/16/8/1478

Application of PET/MRI in Gynecologic Malignancies This article reviews the value of Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) in evaluating female pelvic cancers.