PET/MRI Scan for Cervical Cancer

Overseen By Sanaz Javadi

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Radiation history, Endometrial cancer, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively a PET/MRI scan can help doctors understand the spread of cervical cancer that can be surgically removed. The scan combines two imaging techniques to provide detailed pictures of the cancer. Patients who might be suitable have suspected cervical cancer small enough for surgical removal and plan to have surgery at MD Anderson. This trial could offer important insights into cervical cancer spread, aiding in planning effective treatments. As an Early Phase 1 trial, this research focuses on understanding the imaging technique's function in people, offering participants a chance to contribute to groundbreaking advancements in cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PET/MRI scan is safe for patients with cervical cancer?

Research shows that PET/MRI scans are generally safe and well-tolerated. Previous studies have not identified any major safety issues with PET/MRI imaging itself. This type of scan more effectively assesses the spread of cervical cancer compared to other methods. During these studies, patients received a small amount of a radioactive substance and a contrast dye for the scan. Although the scan can take 90-120 minutes, it is not known to cause harm.

PET/MRI is also used in many medical settings, suggesting a good safety record. However, since this is an early phase trial, the main focus is on the scan's effectiveness rather than safety. If there are any concerns or health conditions, it's always best to consult a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using PET/MRI scans for cervical cancer because this combined imaging approach offers a more detailed view of tumors compared to traditional methods like CT scans or standalone MRIs. This technique combines the metabolic imaging from PET with the anatomical detail from MRI, potentially allowing for more precise detection and staging of cancer. Additionally, the use of fludeoxyglucose F-18 as a tracer can highlight how the cancer cells are metabolizing glucose, which might help in assessing the aggressiveness of the cancer. This could lead to more tailored treatment plans for patients, improving outcomes and reducing unnecessary treatments.

What evidence suggests that the PET/MRI scan is effective for checking cervical cancer?

Studies have shown that PET/MRI scans effectively evaluate cervical cancer. Research indicates that PET/MRI is more accurate than MRI alone in detecting the cancer's local and distant spread. In some cases, PET/MRI provided greater diagnostic confidence and helped identify more advanced disease stages. This can be crucial for better treatment planning. Overall, PET/MRI offers a more detailed and reliable picture of the cancer compared to other imaging methods. Participants in this trial will undergo a PET/MRI scan to assess its effectiveness in diagnosing cervical cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Sanaz Javadi

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with suspected early-stage cervical cancer (IA1-IB3) that can potentially be removed by surgery. Participants must not have tumors larger than 4 cm, should have no issues with undergoing MRI scans, and will be having their surgical procedure at MD Anderson.

Inclusion Criteria

My cervical cancer is in the early stages and my tumor is not larger than 4 cm.

No contraindications to MRI

I am suspected to have cervical cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients receive fludeoxyglucose F-18 and gadobutrol IV and undergo PET/MRI

90-120 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic procedure

3 years

What Are the Treatments Tested in This Trial?

Interventions

• PET/MRI Scan

Trial Overview The study is evaluating the effectiveness of PET/MRI scans using Gadobutrol and Fludeoxyglucose F-18 in assessing the spread of early-stage cervical cancer before surgery.

How Is the Trial Designed?

Group I: Diagnostic (PET/MRI) Experimental Treatment 4 Interventions

Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9858166/

Current Update on PET/MRI in Gynecological ... The combined PET/CT was studied, which showed high sensitivity (91% vs. 37.3%) and diagnostic accuracy (98% vs. 95%) compared to MRI (p < 0.034) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8037915/

PET/MR imaging for the evaluation of cervical cancer ... Based on these reports, PET/MRI is more effective in evaluating cervical cancer progression than other imaging techniques. Additionally, our detection of pelvic ...

3. tech.snmjournals.org tech.snmjournals.org/content/48/4/331

18F-FDG PET/MRI Primary Staging of Cervical Cancer PET/MRI provided greater diagnostic confidence than PET/CT and upstaged the disease in 4 patients. On the basis of the imaging findings alone, ...

4. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-023-01589-1

Diagnostic accuracy of MRI, CT, and [ 18 F]FDG-PET-CT in ... In conclusion, [18F]FDG-PET-CT outperformed MRI and CT in detecting nodal metastases in patients with early-stage cervical cancer with a ...

5. cancerimagingjournal.biomedcentral.com cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-020-00372-5

Diagnostic efficiency of whole-body 18F-FDG PET/MRI, MRI ... PET/MRI shows higher accuracy than MRI alone for determining local tumor spread and distant metastasis emphasizing the added value of PET over MRI alone in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2515618/

The prognostic value of PET and PET/CT in cervical cancer In patients with newly diagnosed cervical cancer, the pooled sensitivity of PET was 79% (95% CI 65–90%), and the pooled specificity was 99% (96–99%) for ...

7. mdpi.com mdpi.com/1718-7729/30/1/83

Current Update on PET/MRI in Gynecological ... PET/MRI has a sensitivity, specificity, and diagnostic accuracy of 91%, 94%, and 93% in detecting nodal metastases [15]. Compared to PET/CT, PET/MRI identifies ...

8. ajronline.org ajronline.org/doi/10.2214/AJR.12.9830

The Role of PET/CT in the Management of Cervical Cancer Several studies have shown 85–90% accuracy of MRI in the detection of malignant tumors larger than 1 cm [20]. MRI can be used for triage of patients to surgery ...

9. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=232

Positron Emission Tomography (FDG) for Cervical Cancer CMS agrees that there is no credible evidence that the results of FDG PET imaging are useful to make the initial diagnosis of cervical cancer.