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Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors

NCT07708103 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-16

No results posted yet for this study

Summary

This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of \[68Ga\]Ga-FFD PET imaging. The study consists of two cohorts: healthy volunteers and adult patients with histologically or clinically confirmed malignant solid tumors. Healthy volunteers will undergo serial PET imaging to evaluate tracer biodistribution, pharmacokinetics, and radiation dosimetry. Patients will undergo \[68Ga\]Ga-FFD PET imaging in addition to standard-of-care \^18F-FDG PET imaging for assessment of lesion detection and diagnostic performance. Safety will be evaluated through adverse event monitoring, vital signs, laboratory tests, physical examinations, and electrocardiography. Diagnostic performance will be assessed using histopathology, conventional imaging, and clinical follow-up as the reference standard.

Conditions

  • Solid Tumor Malignancies

Interventions

DRUG

[68Ga]Ga-FFD

For Cancer patients, \[68Ga\]Ga-FFD is a gallium-68-labeled PET radiotracer administered as a single intravenous injection at approximately 185 MBq (5 mCi ±10%) for molecular imaging. Whole-body PET/CT imaging will be performed at approximately 0.5 and 2 hours after administration to evaluate tracer biodistribution, radiation dosimetry, safety, and diagnostic performance.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2027-07-30
Completion
2027-07-30

Countries

  • China

Study Locations

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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 NCT07708103 on ClinicalTrials.gov