Pilot StudyPhase 2NCT07325253
A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Graft Versus Host Disease Manifestations
A Phase 2 study testing [18F]-4FN and PET-CT in people with Pilot Study and PET/CT Imaging, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To study the safety and possible side effects of using the imaging agent 4-[18F]Fluoro-1-Naphthol (also called [18F]4FN) in PET/CT scans for participants with chronic GVHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilot Study, PET/CT Imaging, Host Disease Manifestation
- What is being tested?
- [18F]-4FN and PET-CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to 3 Jan 2030
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unable to comply with all study procedures (for example, participants who are unable to come to all follow up visits because they live far away from the transplant center)
- Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F]4FN in pregnancy are not known.
- Subjects with contraindications to the use of [18F]4FN including confirmed allergy.
- Participants with a body weight of 400 pounds or more, or a body habitus which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
- Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
George L Chen, MD, 713-792-3630, glchen1@mdanderson.org
George L Chen, MD
About this study
To study the safety and possible side effects of using the imaging agent 4-[18F]Fluoro-1-Naphthol (also called [18F]4FN) in PET/CT scans for participants with chronic GVHD.
Read the detailed description
Primary Objective:
Determine the spatial and temporal correlation between [18F]4FN PET/CT measurements and the clinical manifestations and severity of GVHD. We hypothesize that [18F]4FN PET/CT imaging features will anatomically and by intensity (SUV) correlate with concurrent GVHD manifestations. We also hypothesize that PET/CT imaging features will temporally precede GVHD manifestations at target anatomic locations.
Secondary Objective:
Identify the [18F]4FN PET/CT-positive GVHD lesions responsive to GVHD therapies. As a pharmacodynamic biomarker, we hypothesize that changes in [18F]4FN PET-positive GVHD lesions will correlate with treatments that target macrophages and neutrophils.
- Conditions
- Pilot Study, PET/CT Imaging, Host Disease Manifestation
- Being tested
- [18F]-4FN, PET-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-4FNDrug
Given by IV
PET-CTOther
Imaging
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Prognostic Biomarker Analysis - [18F]4FN PET/CT at Baseline Receives: Drug: [18F]-4FN; Other: PET-CT |
| Part 2 | Experimental | Predictive/PD Biomarker Analysis - [18F]4FN PET/CT before a New Systemic Therapy Receives: Drug: [18F]-4FN; Other: PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start18 Nov 2025
- Primary completion3 Jan 2028 (estimated)
- Study completion3 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilot StudyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George L Chen, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325253
- Sponsor's protocol ID
- 2025-1051
- Other IDs
- NCI-2026-00037
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Graft Versus Host Disease Manifestations
- ClinicalTrials.gov ID
- NCT07325253
- Acronym / sponsor ID
- 2025-1051
- Conditions
- Pilot Study, PET/CT Imaging, Host Disease Manifestation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 3 Jan 2028 (estimated)
- Study completion
- 3 Jan 2030 (estimated)
- First posted
- 8 Jan 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.
To study the safety and possible side effects of using the imaging agent 4-[18F]Fluoro-1-Naphthol (also called [18F]4FN) in PET/CT scans for participants with chronic GVHD.
Detailed description
Primary Objective:
Determine the spatial and temporal correlation between [18F]4FN PET/CT measurements and the clinical manifestations and severity of GVHD. We hypothesize that [18F]4FN PET/CT imaging features will anatomically and by intensity (SUV) correlate with concurrent GVHD manifestations. We also hypothesize that PET/CT imaging features will temporally precede GVHD manifestations at target anatomic locations.
Secondary Objective:
Identify the [18F]4FN PET/CT-positive GVHD lesions responsive to GVHD therapies. As a pharmacodynamic biomarker, we hypothesize that changes in [18F]4FN PET-positive GVHD lesions will correlate with treatments that target macrophages and neutrophils.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: [18F]-4FN, Other: PET-CTPrognostic Biomarker Analysis - [18F]4FN PET/CT at Baseline |
| Part 2 | Experimental | Drug: [18F]-4FN, Other: PET-CTPredictive/PD Biomarker Analysis - [18F]4FN PET/CT before a New Systemic Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Unable to comply with all study procedures (for example, participants who are unable to come to all follow up visits because they live far away from the transplant center)
- Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F]4FN in pregnancy are not known.
- Subjects with contraindications to the use of [18F]4FN including confirmed allergy.
- Participants with a body weight of 400 pounds or more, or a body habitus which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
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 |
|---|---|---|
| [18F]-4FNGiven by IV | Drug | Part 1, Part 2 |
| PET-CTImaging | Other | Part 1, Part 2 |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 17 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
George L Chen, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]-4FN and PET-CT in people with Pilot Study and PET/CT Imaging, run by M.D. Anderson Cancer Center at 1 site in United States.
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 0 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Sep 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 United States. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 George L Chen, MD (713-792-3630, glchen1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year.). 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 17 Sep 2026.