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Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04459273 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Jonsson Comprehensive Cancer Center |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Jeremie Calais |
| Principal Investigator Affiliation | UCLA / Jonsson Comprehensive Cancer Center |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Bladder Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Hepatocellular Carcinoma, Malignant Adrenal Gland Neoplasm, Malignant Brain Neoplasm, Malignant Pleural Neoplasm, Malignant Skin Neoplasm, Malignant Solid Neoplasm, Malignant Testicular Neoplasm, Malignant Thymus Neoplasm, Neuroendocrine Neoplasm, Thyroid Gland Carcinoma, Urothelial Carcinoma, Cancer of Unknown Primary Site |
Contact a Trial Team
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