68Ga-FAPI-46 for Cancer
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 is best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment 68Ga-FAPI-46 for cancer?
Research shows that 68Ga-FAPI, a similar compound, is effective in diagnosing various cancers, including gastrointestinal cancer, by highlighting tumors in imaging tests. This suggests that 68Ga-FAPI-46 could also be effective in identifying cancerous areas, which can help in managing the disease.12345
Is 68Ga-FAPI-46 safe for use in humans?
68Ga-FAPI has been used in various studies for imaging tumors and other conditions, and it has shown promising results in both preclinical and clinical settings. While specific safety data for 68Ga-FAPI-46 is not detailed, the use of similar compounds in humans suggests it is generally considered safe for diagnostic purposes.12346
How does the drug 68Ga-FAPI-46 differ from other cancer treatments?
68Ga-FAPI-46 is unique because it targets the fibroblast activation protein, which is often found in the supportive tissue around tumors. This makes it a promising tool for both diagnosing and potentially treating various cancers, offering a different approach compared to traditional treatments that may not specifically target this protein.14789
What is the purpose of this trial?
This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 participants will receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after received the study drug. Imaging will occur before starting standard antibody-based therapy. Participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.
Research Team
Eben Rosenthal, MD
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Eligibility Criteria
This trial is for adults over 19 with any stage of solid tumor cancer, confirmed by biopsy, who are about to start antibody-based therapy. They must have good kidney function and acceptable lab results.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging and Initial Assessment
Participants receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after. A CT/MRI with contrast is performed approximately one week after the study drug infusion and scan.
Treatment
Participants proceed with standard antibody-based therapy as determined by their primary treatment team.
Follow-up
Participants are monitored through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.
Treatment Details
Interventions
- 68Ga-FAPI-46
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eben Rosenthal
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborator
Vanderbilt University Medical Center
Collaborator