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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to find out whether the researchers can combine information provided by PET/MRI scans with information from tests on blood and tissue samples to develop a very detailed description (profile) of high-grade serous ovarian carcinoma (HGSOC), which could improve our ability to treat this disease. The study researchers will use computers to analyze the combined results of the imaging tests and the genetic and immune system tests on the tumor samples. The study researchers think that this information will help them more accurately predict the way tumors respond to treatment, which may improve their ability to individualize treatments for this disease.

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 data supports the effectiveness of the treatment Contrast enhanced CT, PET/MRI for ovarian cancer?

Research shows that using contrast-enhanced CT and PET/CT can accurately locate recurrent ovarian cancer and help predict patient survival. Additionally, combining PET with CT or MRI can improve the detection of ovarian cancer compared to using CT or MRI alone. ^{1 2 3 4 5}

Is advanced imaging for ovarian cancer safe for humans?

The studies reviewed focus on the effectiveness of imaging techniques like CT, MRI, and PET for diagnosing ovarian cancer, but they do not report any specific safety concerns related to these imaging methods. Generally, these imaging techniques are considered safe for humans, though they may involve exposure to radiation or contrast agents. ^{2 5 6 7 8}

How does advanced imaging differ from other treatments for ovarian cancer?

Advanced imaging for ovarian cancer, such as FDG-PET/CT, offers a more accurate diagnosis by combining PET scans with contrast-enhanced CT, which helps in better identifying and staging the cancer compared to traditional imaging methods. This approach can provide additional information that may improve treatment planning and monitoring. ^{2 5 7 9 10}

Research Team

Viktoriya Paroder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Recurrent ovarian cancer: use of contrast-enhanced CT and PET/CT to accurately localize tumor recurrence and to predict patients' survival. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Indirect comparison of the diagnostic performance of 18F-FDG PET/CT and MRI in differentiating benign and malignant ovarian or adnexal tumors: a systematic review and meta-analysis. [2021]

3. Singapore pubmed.ncbi.nlm.nih.gov

Positron emission tomography in the management of documented or suspected recurrent ovarian cancer. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

Advanced ovarian carcinoma: usefulness of [(18)F]FDG-PET in combination with CT for lesion detection after primary treatment. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of positron emission tomography with tracer 18-fluorodeoxyglucose in addition to magnetic resonance imaging in the diagnosis of ovarian cancer in selected women after ultrasonography. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

CT and MRI findings of type I and type II epithelial ovarian cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Primary ovarian cancer: prospective comparison of contrast-enhanced CT and pre-and postcontrast, fat-suppressed MR imaging, with histologic correlation. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Low-dose non-enhanced CT versus full-dose contrast-enhanced CT in integrated PET/CT scans for diagnosing ovarian cancer recurrence. [2015]

9. Japan pubmed.ncbi.nlm.nih.gov

Present and future of FDG-PET/CT in ovarian cancer. [2016]

10. Germany 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. [2021]