Solid Tumor CancerEarly Phase 1NCT06922825
Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients
A Early Phase 1 study testing 68Ga-FAPI-46 in people with Solid Tumor Cancer and Solid Tumor Malignancy, run by Eben Rosenthal at 1 site in United States.
Trial summary
This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor Cancer, Solid Tumor Malignancy, Cancer
- What is being tested?
- 68Ga-FAPI-46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Sep 2032
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years.
- Biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy
- Subjects diagnosed with any stage of disease who will undergo immunotherapy treatment.
- Have acceptable kidney function and clinical lab values.
Who cannot join
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- Females who are currently pregnant or breastfeeding
- Severe renal disease or anuria
- Inability to lie flat or remain still for the duration of the scan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Study Evaluating 68Ga-FAPI-46 Tumor Microenvironment Interaction in Solid Tumor Patients
This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 participants will receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after received the study drug. Imaging will occur before starting standard antibody-based therapy. Participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.
Read the detailed description
This is a pilot study to compare PET/CT uptake of 68Ga-FAPI-46 to uptake parameters determined by Standard of Care MRI or CT with contrast. Patients with a solid tumor diagnosis who are scheduled to undergo biologic therapy will be included in the study. Following imaging, patients will begin standard of care antibody based therapy and standard of care follow-up.
This study is an open label, single institution, pilot study to determine if 68-Ga-FAPI-46 can predict tumor uptake in patients with solid tumor and if the 68-Ga-FAPI-46 uptake in the tumor positively correlates with response to antibody based therapies.
A total of 50 subjects will be enrolled in the study. Imaging will take place prior to initiation of treatment. Patients will then be administered an intravenous injection of 68-Ga-FAPI-46 after which subjects will undergo a PET/CT scan shortly after receiving the drug. Subjects will then undergo treatment as determined by their primary team. The study team will chart review subjects for 36 months ± 6 months with the possibility of extending this follow-up depending on immunotherapy treatment duration to extract treatment response information as documented by their primary treatment team.
Total duration of active participation per patient may last approximately 45 days.
The study will take around 84 ± 6 months from the time the study opens to accrual. The total duration per patient from time of enrollment to chart review is 36 ± 6 months.
- Conditions
- Solid Tumor Cancer, Solid Tumor Malignancy, Cancer, Malignancy
- Being tested
- 68Ga-FAPI-46
- Keywords
- Immunotherapy, anti-body based therapy, abt, antibody based therapy, anti body based therapy, cancer, malignancy, solid tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-46Drug
Participants will receive an IV injection of 68Ga-FAPI-46. Then, shortly after will undergo a PET/CT imaging using the 68Ga-FAPI-46. Additionally, MRI or contrast CT imaging will be conducted, either on the same day or within 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 68 Ga FAPI-46 | Experimental | Each participant who meets criteria will receive one dose of 68 Ga FAPI-46 via IV and then receive a whole body PET/CT Scan the same day of infusion. Participants will be asked to have a CT/MRI with contrast approximately one week after the study drug infusion and scan.
Researchers will compare PET/CT images using 68Ga-FAPI-46 to compare uptake determined by MRI or CT with contrast as usual Standard of Care. Receives: Drug: 68Ga-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the correlative relationship between 68Ga-FAPI-46 and tumor uptake.
PET/CT uptake of 68Ga-FAPI-46 will be compared to uptake parameters determined by MRI or CT with contrast.
Measured: Day 1 Scan to Day 15 Scan.
Secondary outcomes (1)
Assess the ability of 68Ga-FAPI-46 to predict response to ABT
PET/CT imaging with 68Ga-FAPI-46 agent administration (study drug) will be compared to predictive capability of conventional scoring systems (e.g., PD-L1 CPS) scoring from patient biopsy specimens (gold standard). Treatment response values will be determined by the patient's primary treatment team per standard of care assessment.
The analysis is exploratory, intended to generate preliminary data for future studies. The proposed sample size is 50 subjects, with approximately two-thirds undergoing contrast-enhanced CT and one-third undergoing MRI. Based on simulations, the margin of error for a 95% confidence interval is expected to range from 0.13 to 0.26 for n = 37, depending on the true correlation (0.8 to 0.5), and from 0.21 to 0.37 for n = 13.
Measured: Day 1 Scan to Day 30 follow up with physician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study startJan 2027 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionSep 2032 (estimated)
Why it stopped: No patients enrolled onto study. Administratively withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eben Rosenthal
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center
- Responsible party
- Sponsor-investigator, Eben Rosenthal, Vanderbilt-Ingram Cancer Center
- Investigators
- Eben Rosenthal, MD, Study director, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922825
- Sponsor's protocol ID
- VICCHN25009
- Status last verified
- Jul 2025
- First submitted
- 3 Apr 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study, and the sample size is not designed to support confirmatory conclusions. The analysis is exploratory, intended to generate preliminary data for future studies.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating 68Ga-FAPI-46 Tumor Microenvironment Interaction in Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT06922825
- Acronym / sponsor ID
- VICCHN25009
- Conditions
- Solid Tumor Cancer, Solid Tumor Malignancy, Cancer, Malignancy
- Keywords
- Immunotherapy, anti-body based therapy, abt, antibody based therapy, anti body based therapy, cancer, malignancy, solid tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled onto study. Administratively withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eben RosenthalUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 11 Apr 2025 (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 pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 participants will receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after received the study drug. Imaging will occur before starting standard antibody-based therapy. Participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.
Detailed description
This is a pilot study to compare PET/CT uptake of 68Ga-FAPI-46 to uptake parameters determined by Standard of Care MRI or CT with contrast. Patients with a solid tumor diagnosis who are scheduled to undergo biologic therapy will be included in the study. Following imaging, patients will begin standard of care antibody based therapy and standard of care follow-up.
This study is an open label, single institution, pilot study to determine if 68-Ga-FAPI-46 can predict tumor uptake in patients with solid tumor and if the 68-Ga-FAPI-46 uptake in the tumor positively correlates with response to antibody based therapies.
A total of 50 subjects will be enrolled in the study. Imaging will take place prior to initiation of treatment. Patients will then be administered an intravenous injection of 68-Ga-FAPI-46 after which subjects will undergo a PET/CT scan shortly after receiving the drug. Subjects will then undergo treatment as determined by their primary team. The study team will chart review subjects for 36 months ± 6 months with the possibility of extending this follow-up depending on immunotherapy treatment duration to extract treatment response information as documented by their primary treatment team.
Total duration of active participation per patient may last approximately 45 days.
The study will take around 84 ± 6 months from the time the study opens to accrual. The total duration per patient from time of enrollment to chart review is 36 ± 6 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68 Ga FAPI-46 | Experimental | Drug: 68Ga-FAPI-46Each participant who meets criteria will receive one dose of 68 Ga FAPI-46 via IV and then receive a whole body PET/CT Scan the same day of infusion. Participants will be asked to have a CT/MRI with contrast approximately one week after the study drug infusion and scan. Researchers will compare PET/CT images using 68Ga-FAPI-46 to compare uptake determined by MRI or CT with contrast as usual Standard of Care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 19 years.
- Biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy
- Subjects diagnosed with any stage of disease who will undergo immunotherapy treatment.
- Have acceptable kidney function and clinical lab values.
Key exclusion criteria (4 listed)
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- Females who are currently pregnant or breastfeeding
- Severe renal disease or anuria
- Inability to lie flat or remain still for the duration of the scan.
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-FAPI-46Participants will receive an IV injection of 68Ga-FAPI-46. Then, shortly after will undergo a PET/CT imaging using the 68Ga-FAPI-46. Additionally, MRI or contrast CT imaging will be conducted, either on the same day or within 14 days. | Drug | 68 Ga FAPI-46 |
Primary outcome
Determine the correlative relationship between 68Ga-FAPI-46 and tumor uptake.
Time frame: Day 1 Scan to Day 15 Scan.
PET/CT uptake of 68Ga-FAPI-46 will be compared to uptake parameters determined by MRI or CT with contrast.
1 secondary outcome
Assess the ability of 68Ga-FAPI-46 to predict response to ABT
Time frame: Day 1 Scan to Day 30 follow up with physician
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. This is a pilot study, and the sample size is not designed to support confirmatory conclusions. The analysis is exploratory, intended to generate preliminary data for future studies.
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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. This study is not recruiting at the moment.
Eben Rosenthal, MD study director
Vanderbilt University/Ingram Cancer Center
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-FAPI-46 in people with Solid Tumor Cancer and Solid Tumor Malignancy, run by Eben Rosenthal 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 21 Jan 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?
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the correlative relationship between 68Ga-FAPI-46 and tumor uptake. (time frame: Day 1 Scan to Day 15 Scan.). 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 21 Jan 2026.