Cancer
Conditions
Brief summary
This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is lighting up and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.
Detailed description
PRIMARY OBJECTIVE: To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI. OUTLINE: Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later. After completion of study, patients are followed up at 24-72 hours.
Interventions
DRUG68Ga-FAPI
68Ga-FAPI is quinoline based PET radiopharmaceutical. 68Ga-FAPI is administered intravenously (IV)
PROCEDUREComputed Tomography (CT) scan
Participants will have a CT scan for attenuation correction and anatomic localization of PET data.
PET images will be acquired.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient with current malignancy confirmed via pathology or imaging * Patient must be \> 18 years old * Patient must be willing and able to provide written informed consent for the trial * Patient of reproductive potential will have a pregnancy test
Exclusion criteria
* Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of 68Ga-FAPI PET | 24 months | Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if \> 50% of scans will have a score of 3 or more |
Countries
United States
Outcome results
None listed