Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors… (NCT07118176) | Clinical Trial Compass
RecruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
United States30 participantsStarted 2025-08-01
Plain-language summary
This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with the following suspected or diagnosed cancer types:
* Adrenal cancer
* Anal cancer
* Bladder cancer
* Brain cancer
* Breast cancer
* Cancer of unknown primary (CUP)
* Cervical cancer
* Cholangiocarcinoma
* Colorectal cancer
* Esophageal cancer
* Gastric cancer
* Head and neck cancer
* Hematologic cancer
* Hepatocellular carcinoma
* Lung cancer
* Medullary thyroid cancer
* Neuroendocrine neoplasias
* Ovarian cancer
* Pancreatic cancer
* Penile cancer
* Peritoneal cancer
* Pleural cancer
* Prostate cancer
* Sarcoma
* Salivary gland cancer
* Solitary fibrous tumor
* Skin cancer
* Testicular cancer
* Thymus cancer
* Thyroid cancer
* Urothelial cancer
* Uterus cancer
* Vaginal cancer
* Patients are ≥ 18 years old at the time of the radiotracer administration
* Patient can provide written informed consent
* Patient is able to remain still for duration of imaging procedure (up to one hour)
Exclusion Criteria:
* Patient is pregnant or nursing
* Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high-quality data
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)