Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients

Launched by EBEN ROSENTHAL · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study how a specific imaging technique, using a substance called 68Ga-FAPI-46, compares to standard imaging methods like MRI or CT scans in patients with solid tumors who are about to start treatment with biologic therapy. The goal is to see if this new imaging can provide better information about tumors, which may help doctors understand how well the treatment is working over time. The study will involve 50 participants who will receive an injection of 68Ga-FAPI-46 and then have a PET/CT scan shortly after. After the scans, they will begin their regular treatment and the researchers will monitor their progress for up to three years.

To join this trial, participants must be at least 19 years old and have a confirmed diagnosis of solid tumor cancer that is scheduled for antibody-based treatment. They should also have good kidney function and meet certain health criteria. However, those with recent serious heart issues, severe liver disease, or who are pregnant or breastfeeding cannot participate. During the study, participants can expect to receive an injection and undergo a scan, which will require them to lie still for a short period. This research aims to improve the way we monitor treatment responses in cancer patients, potentially leading to better outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 19 years.
• • Biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy
• • Subjects diagnosed with any stage of disease who will undergo immunotherapy treatment.
• • Have acceptable kidney function and clinical lab values.
• Exclusion Criteria:
• • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
• • Females who are currently pregnant or breastfeeding
• • Severe renal disease or anuria
• • Inability to lie flat or remain still for the duration of the scan.