Solid Tumor MalignanciesEarly Phase 1NCT07708103
Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors
A Early Phase 1 study testing [68Ga]Ga-FFD in people with Solid Tumor Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- [68Ga]Ga-FFD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaoli Lan, 0086-027-83692633, lxl730724@hotmail.com
lxl730724@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor Malignancies
- Being tested
- [68Ga]Ga-FFD
- Keywords
- pet, Solid Tumor, Biodistribution, Diagnostic Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FFDDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: [68Ga]Ga-FFD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events
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.
Measured: From administration of [68Ga]Ga-FFD through 7 days after PET imaging.
Biodistribution of [68Ga]Ga-FFD
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.
Measured: Approximately 0.5 hours and 2 hours after tracer administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708103
- Sponsor's protocol ID
- Xlan-20260332
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07708103
- Acronym / sponsor ID
- Xlan-20260332
- Conditions
- Solid Tumor Malignancies
- Keywords
- pet, Solid Tumor, Biodistribution, Diagnostic Imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-FFD PET Imaging | Experimental | Drug: [68Ga]Ga-FFDParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FFDFor 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. | Drug | [68Ga]Ga-FFD PET Imaging |
Primary outcome
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.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [68Ga]Ga-FFD in people with Solid Tumor Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Lan (0086-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual and standardized uptake values assessment of lesions and biodistribution (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.