- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459273
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers (FAPI PET RDRC)
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
Study Overview
Status
Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
- Hepatocellular Carcinoma
- Cholangiocarcinoma
- Cervical Carcinoma
- Urothelial Carcinoma
- Bladder Carcinoma
- Thyroid Gland Carcinoma
- Neuroendocrine Neoplasm
- Malignant Skin Neoplasm
- Malignant Brain Neoplasm
- Cancer of Unknown Primary Site
- Malignant Adrenal Gland Neoplasm
- Malignant Pleural Neoplasm
- Malignant Testicular Neoplasm
- Malignant Thymus Neoplasm
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).
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Ethan Lam
- Phone Number: 310-206-7372
- Email: eclam@mednet.ucla.edu
Study Contact Backup
- Name: Stephanie Lira
- Phone Number: 310-206-7372
- Email: StephanieLira@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA / Jonsson Comprehensive Cancer Center
-
Contact:
- Ethan Lam
- Phone Number: 310-206-7372
- Email: eclam@mednet.ucla.edu
-
Principal Investigator:
- Jeremie Calais
-
Contact:
- Stephanie Lira
- Phone Number: 310-206-7372
- Email: StephanieLira@mednet.ucla.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Basic science (68GA-FAPI-46 PET/CT)
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).
|
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues
Time Frame: At 20-90 minutes after injection]
|
Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).
|
At 20-90 minutes after injection]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)
Time Frame: Up to year 2
|
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
Time Frame: 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-)
|
up to 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers
Time Frame: 60 minutes after tracer injection
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeremie Calais, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Endocrine System Diseases
- Gonadal Disorders
- Pleural Diseases
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Thyroid Diseases
- Head and Neck Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neoplastic Processes
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasm Metastasis
- Adrenal Gland Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Neoplasms
- Testicular Neoplasms
- Carcinoma
- Thymus Neoplasms
- Urinary Bladder Neoplasms
- Brain Neoplasms
- Cholangiocarcinoma
- Skin Neoplasms
- Thyroid Neoplasms
- Neuroendocrine Tumors
- Neoplasms, Unknown Primary
- Adrenal Gland Neoplasms
- Pleural Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
- FAPI-46
Other Study ID Numbers
- 20-000630
- NCI-2020-03766 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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