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

NCT07708103 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Xlan-20260332
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pet; Solid Tumor; Biodistribution; Diagnostic Imaging

Outcome Measures

Primary Outcomes (1)

• Visual and standardized uptake values assessment of lesions and biodistribution

  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 Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  From administration of [68Ga]Ga-FFD through 7 days after PET imaging.

• Biodistribution of [68Ga]Ga-FFD

  Approximately 0.5 hours and 2 hours after tracer administration.

Study Arms (1)

[68Ga]Ga-FFD PET Imaging

EXPERIMENTAL

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

Interventions

[68Ga]Ga-FFD DRUG

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.

[68Ga]Ga-FFD PET Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Central Study Contacts

Xiaoli Lan

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)