Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Vari… (NCT04459273) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
United States26 participantsStarted 2020-08-27
Plain-language summary
This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.
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 cancer types:
* Brain cancer
* Bladder cancer
* Urothelial cancer
* Testicular cancer
* Skin cancer
* Thyroid cancer
* Hepatocellular carcinoma
* Cholangiocarcinoma
* Thymus cancer
* Pleural cancer
* Cervical cancer
* Adrenal cancer
* Neuroendocrine tumors
* Hematologic cancer
* Cancer of Unkown Primary
* Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
* 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
* Patients with any new cancer therapy between the baseline PET/CT and the investigational FAPI PET/CT
* 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 68Ga-FAPi-46 in normal and cancer tissues