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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04961 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.
PRIMARY OBJECTIVE:
I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies measured by standardized uptake values (SUV).
SECONDARY OBJECTIVE:
I. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (68Ga-FAPi-46 PET/CT) | Experimental | Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) | Will be evaluated in normal and cancer tissues by standardized uptake values to determine where and to which degree 68Ga-FAPi-46 accumulates in normal and cancer tissues. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Fludeoxyglucose F-18 (18F-FDG) biodistribution | Will assess the correlation between 68Ga-FAPi-46 biodistribution and 18F-FDG biodistribution and define the frequency of the following phenotypes: 68Ga-FAPi-46 (FAP)+/fludeoxyglucose F-18 (FDG)+, FAP-/FDG+, FAP+/FDG-, FAP-/FDG-. | Up to 2 years |
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Inclusion Criteria:
Patients with the following suspected or diagnosed cancer types:
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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| Fludeoxyglucose F-18 | Other | Given IV |
|
|
| Gallium Ga 68 FAPi-46 | Radiation | Given IV |
|
|
| Positron Emission Tomography | Procedure | Undergo PET/CT |
|
|
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D018281 | Cholangiocarcinoma |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D008175 | Lung Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D001932 | Brain Neoplasms |
| D013736 | Testicular Neoplasms |
| D014594 | Uterine Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010412 | Penile Neoplasms |
| D011471 | Prostatic Neoplasms |
| D012468 | Salivary Gland Neoplasms |
| D012509 | Sarcoma |
| D054364 | Solitary Fibrous Tumors |
| D013964 | Thyroid Neoplasms |
| D018276 | Carcinoma, Medullary |
| D002295 | Carcinoma, Transitional Cell |
| D014625 | Vaginal Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| 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 |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract 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 |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D010182 | Pancreatic Diseases |
| D010409 | Penile Diseases |
| D011469 | Prostatic Diseases |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D013959 | Thyroid Diseases |
| D018278 | Carcinoma, Neuroendocrine |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D014623 | Vaginal Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| C000706531 | FAPI-46 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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