An Early Phase 1 interventional study of 68Ga-FAPI-46 in Solid Tumor Cancer, Solid Tumor Malignancy and Cancer, sponsored by Eben Rosenthal. Withdrawn at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Eben Rosenthal · Early Phase 1, Interventional, and Basic science
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.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 68Ga-FAPI-46
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.
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.
Time frame: Day 1 Scan to Day 15 Scan.
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.
Time frame: Day 1 Scan to Day 30 follow up with physician
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Apr 2032, 63 months later.
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This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FAPI-46
Eben Rosenthal