FDG-PET/CT Assessment for Breast Cancer

Recruiting in Palo Alto (17 mi)

+111 other locations

Specht | Division of Hematology & Oncology

Overseen ByJennifer M. Specht

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial studies how well certain scans work in assessing the response of patients with breast cancer that has spread to the bones. The scans use a special substance to highlight active cancer areas on detailed body images, helping doctors see if the treatment is working. These scans have been used successfully for various stages and evaluations of breast cancer.

Eligibility Criteria

This trial is for patients with breast cancer that has spread to the bones. Participants must have a life expectancy of at least 24 weeks, an ECOG performance status of <=2, and meet renal function guidelines. They should plan to receive specific systemic therapies like endocrine therapy or chemotherapy. Pregnant or breastfeeding women, those with certain other cancers or who've had extensive chemotherapy are excluded.

Inclusion Criteria

My breast cancer has spread, is hormone receptor positive, and my HER2 status is known.

My kidney function is good enough for MRI and CT scans.

I can take care of myself but might not be able to do heavy physical work.

My cancer is mainly in my bones.

Exclusion Criteria

My cancer has not spread to my brain, membranes around the brain and spine, or filled my chest or abdomen cavities.

I have not had more than 3 chemotherapy treatments for my advanced breast cancer.

Participant Groups

The FEATURE study is testing how well FDG-PET/CT scans measure activity in bone-dominant metastatic breast cancer before and after treatment compared to standard imaging tests. This phase II trial aims to improve diagnostic accuracy for assessing responses in these patients.

1Treatment groups

Experimental Treatment

Group I: Diagnostic (FDG-PET/CT)Experimental Treatment3 Interventions

Patients receive FDG IV and undergo PET/CT scan over 15-30 minutes at baseline (within 21 days before start of standard systemic treatment) and at 12 weeks after start of standard systemic treatment in the absence of unacceptable toxicity.