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

July 12, 2026 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

A Single-Center, Prospective, Open-Label Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Diagnostic Performance of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Adult Patients With Solid Tumors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This first-in-human study evaluates the clinical performance of [68Ga]Ga-FFD, a novel PET radiotracer for molecular imaging of malignant tumors. Healthy volunteers will undergo serial whole-body PET imaging after a single intravenous administration of [68Ga]Ga-FFD to characterize biodistribution, organ uptake, pharmacokinetics, and radiation dosimetry. Adult patients with malignant solid tumors will undergo [68Ga]Ga-FFD PET/CT and standard-of-care ^18F-FDG PET/CT imaging. Diagnostic performance, including lesion detection and patient-based diagnostic accuracy, will be compared between the two imaging modalities. Radiation dosimetry will be estimated using time-activity curves and the OLINDA/EXM software based on the MIRD methodology. Safety assessments will include adverse events, laboratory evaluations, electrocardiography, physical examinations, and vital signs.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Written informed consent obtained before any study-specific procedures. Adults aged 18 years or older.
  • Healthy volunteers or patients with histologically, cytologically, or clinically confirmed malignant solid tumors.
  • ECOG performance status of 0-1 for patients.
  • Clinical indication for ^18F-FDG PET/CT imaging (patient cohort only).
  • Adequate organ function.
  • Willing and able to comply with all study procedures.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Known hypersensitivity to gallium-containing radiopharmaceuticals or any component of the investigational product.
  • Clinically significant uncontrolled cardiovascular, hepatic, renal, hematologic, neurological, or psychiatric disease.
  • Active uncontrolled infection requiring systemic treatment.
  • Receipt of investigational drugs or participation in another interventional clinical study within 30 days before enrollment.
  • Previous anticancer therapy that does not satisfy the protocol-defined washout period (patient cohort only).
  • Inability to undergo PET/CT imaging or comply with study procedures. Any condition that, in the investigator's judgment, would compromise participant safety or interfere with study assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [68Ga]Ga-FFD PET Imaging
Participants will receive a single intravenous administration of [68Ga]Ga-FFD followed by serial whole-body PET/CT imaging. Healthy volunteers will undergo imaging for biodistribution and radiation dosimetry evaluation, while patients with malignant solid tumors will additionally undergo standard-of-care ^18F-FDG PET/CT imaging for assessment of diagnostic performance.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual and standardized uptake values assessment of lesions and biodistribution
Time Frame: one month
PET images will be independently reviewed by at least two experienced nuclear medicine physicians who are blinded to each other's interpretations. Histopathological findings, when available, together with clinical and imaging follow-up, will serve as the reference standard for lesion verification. Both visual and semiquantitative analyses will be performed for each participant. Semiquantitative analysis will include measurement of the maximum and mean standardized uptake values (SUVmax and SUVmean) of tumor lesions and major normal organs at each imaging time point. Lesion detection, tracer biodistribution, tumor-to-background ratios, and image quality will also be evaluated.
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: From administration of [68Ga]Ga-FFD through 7 days after PET imaging.
Safety will be evaluated by assessing the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), together with changes in vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms following administration of [68Ga]Ga-FFD.
From administration of [68Ga]Ga-FFD through 7 days after PET imaging.
Biodistribution of [68Ga]Ga-FFD
Time Frame: Approximately 0.5 hours and 2 hours after tracer administration.
Percentage of injected dose (%ID), SUVmean, and residence time in major organs and tissues will be measured at each imaging time point. Time-activity curves will be generated for quantitative biodistribution analysis.
Approximately 0.5 hours and 2 hours after tracer administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 30, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Xlan-20260332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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