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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03766 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic science (68GA-FAPI-46 PET/CT) | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues | Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax). | At 20-90 minutes after injection] |
| Measure | Description | Time Frame |
|---|---|---|
| 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT) | Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue. | Up to year 2 |
| 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers | The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation. | 60 minutes after tracer injection |
Inclusion Criteria:
Patients with the following cancer types:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremie Calais | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Gallium Ga 68 FAPi-46 | Drug | Given IV |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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| 18F-FDG | Radiation | Given IV |
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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-) |
| up to 2 years |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D018281 | Cholangiocarcinoma |
| D019337 | Hematologic Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D000310 | Adrenal Gland Neoplasms |
| D001932 | Brain Neoplasms |
| D012878 | Skin Neoplasms |
| D013736 | Testicular Neoplasms |
| D013953 | Thymus Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D013964 | Thyroid Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D009382 | Neoplasms, Unknown Primary |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D013899 | Thoracic Neoplasms |
| D008206 | Lymphatic Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D006258 | Head and Neck Neoplasms |
| D013959 | Thyroid Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000706531 | FAPI-46 |
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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