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Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers (FAPI PET RDRC)

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ClinicalTrials.gov Identifier: NCT04459273
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Procedure: Computed Tomography Drug: Gallium Ga 68 FAPi-46 Procedure: Positron Emission Tomography Radiation: 18F-FDG Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).
 Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: Gallium Ga 68 FAPi-46
Given IV
Other Names:
  • 68Ga-FAPi-46
  • Gallium-68-FAPi-46

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Radiation: 18F-FDG
Given IV
Other Name: 18F-fluorodeoxyglucose


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  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-)


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459273


Contacts
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Contact: Andrea Limon 310-206-7372 AndreaLimon@mednet.ucla.edu
Contact: Ethan Lam 310-206-7372 eclam@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Andrea Limon    310-206-7372    AndreaLimon@mednet.ucla.edu   
Contact: Ethan Lam    310-206-7372    eclam@mednet.ucla.edu   
Principal Investigator: Jeremie Calais         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04459273    
Other Study ID Numbers: 20-000630
NCI-2020-03766 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Cholangiocarcinoma
Brain Neoplasms
Urinary Bladder Neoplasms
Neuroendocrine Tumors
Thyroid Neoplasms
Skin Neoplasms
Testicular Neoplasms
Pleural Neoplasms
Neoplasms, Unknown Primary
Thymus Neoplasms
Adrenal Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Adenocarcinoma
Neoplasms by Site
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases