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Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients

NCT06922825 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2026-01-21

No results posted yet for this study

Summary

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.

Conditions

  • Solid Tumor Cancer
  • Solid Tumor Malignancy
  • Cancer
  • Malignancy

Interventions

DRUG

68Ga-FAPI-46

Participants will receive an IV injection of 68Ga-FAPI-46. Then, shortly after will undergo a PET/CT imaging using the 68Ga-FAPI-46. Additionally, MRI or contrast CT imaging will be conducted, either on the same day or within 14 days.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Vanderbilt-Ingram Cancer Center

    collaborator OTHER

  • Eben Rosenthal

    lead OTHER

Principal Investigators

  • Eben Rosenthal, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2032-04-30
Completion
2032-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922825 on ClinicalTrials.gov