PET/MR vs CECT Scans for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Gadolinium allergy, Pacemakers, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

21 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of PET/MR vs CECT scans for ovarian cancer treatment?

Research shows that combining PET scans with CT can improve the detection of ovarian cancer recurrence and help predict patient survival better than using CT alone. Additionally, PET/CT and MRI are both effective in distinguishing between benign and malignant ovarian tumors. ^{1 2 3 4 5}

Is it safe to use PET/MR and CECT scans for ovarian cancer?

PET/CT scans, which combine positron emission tomography (PET) and computed tomography (CT), are generally considered safe for diagnosing and monitoring ovarian cancer. They can detect disease in tissues that appear normal on CT alone and are more reliable than conventional imaging techniques. However, as with any imaging involving radiation, there is a small risk, but it is typically outweighed by the benefits of accurate diagnosis and treatment planning. ^{1 4 6 7 8}

How does Dynamic Enhanced CT differ from other treatments for ovarian cancer?

Dynamic Enhanced CT is unique because it uses a contrast agent to enhance the images of the ovaries, which helps in better visualization of the tumor's internal structure and its relationship with nearby organs. This can provide more detailed information compared to standard CT scans, potentially leading to more accurate diagnosis and staging of ovarian cancer. ^{1 3 8 9 10}

What is the purpose of this trial?

This trial studies how well positron emission tomography/magnetic resonance (PET/MR) versus contrast enhanced computerized tomography (CECT) scans work in locating ovarian cancer tumors in patients with known or suspected ovarian cancer. PET, MR, and CECT scans use different methods to create images of areas inside the body. 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 predict how patients respond to platinum-based chemotherapies compared to standard of care CECT scans.

Research Team

Priya R. Bhosale

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with confirmed or suspected ovarian cancer who can undergo laparoscopic surgery to see if tumors can be removed. They must have a kidney function test (eGFR) over 30. It's not for those allergic to gadolinium, with eGFR under 30, pacemakers, pregnant women, children, weigh over 400 pounds, or high blood sugar.

Inclusion Criteria

Your kidney function, as measured by eGFR, is above 30.

I have or am suspected to have ovarian cancer and can have surgery to see if it can be removed.

Exclusion Criteria

My kidney function is severely reduced.

Your blood sugar level is higher than 200 milligrams per deciliter.

Pregnant women.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Patients undergo standard of care CECT scan and PET-MRI scan over 90-120 minutes within 30 days before laparoscopy or cytoreduction.

4 weeks

1 visit (in-person)

Chemotherapy

Patients who do not undergo cytoreduction based on diagnostic laparoscopy undergo additional PET-MRI and standard of care CECT scans after completion of chemotherapy and before cytoreduction.

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• Dynamic Enhanced CT
• Magnetic Resonance Imaging
• Positron Emission Tomography

Trial Overview The study compares PET/MR scans against standard CECT scans in detecting and assessing ovarian cancer tumors. It aims to determine if PET/MR provides better information on tumor location, surgical removal success prediction and response to platinum-based chemotherapy.

Participant Groups

Group I: Diagnostic (CECT, PET-MRI) Experimental Treatment 3 Interventions

Patients undergo standard of care CECT scan and PET-MRI scan over 90-120 minutes within 30 days before laparoscopy or cytoreduction. Patients who do not undergo cytoreduction based on diagnostic laparoscopy undergo additional PET-MRI and standard of care CECT scans after completion of chemotherapy and before cytoreduction.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

References

1. 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]

2. 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]

3. 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]

4. 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]

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

Role of CT and MR imaging in predicting optimal cytoreduction of newly diagnosed primary epithelial ovarian cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

CT appearances and prognostic significance of splenic metastasis in ovarian cancer. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Surveillance of patients after initial treatment of ovarian cancer. [2016]

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

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

9. 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]

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

Assessment of combination of contrast-enhanced magnetic resonance imaging and positron emission tomography/computed tomography for evaluation of ovarian masses. [2015]