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
Conditions
Brief 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.
Detailed description
PRIMARY OBJECTIVE: I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies. SECONDARY OBJECTIVES: I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue. II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-) EXPERIMENTAL OBJECTIVE: To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available OUTLINE: Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT
RADIATION18F-FDG
Given IV
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues | At 20-90 minutes after injection] | Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT) | Up to year 2 | Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue. |
| 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution | up to 2 years | 2\. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeremie Calais
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed