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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 : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE July 1, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date February 24, 2023
Actual Study Start Date  ICMJE August 27, 2020
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)		 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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)		 To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues [ Time Frame: At 60 minutes after injection ]
To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values [SUV]). The 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2022)
  • 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.
  • 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-)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2020)		 To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of fibroblast activation protein (FAP) assessed by immunohistochemistry (IHC) in excised cancer tissue [ Time Frame: Up to date of surgery (range 1-90 days) ]
68Ga-FAPi-46 tumor SUVs will be correlated with FAP expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
Current Other Pre-specified Outcome Measures
 (submitted: July 6, 2020)		 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.
Original Other Pre-specified Outcome Measures
 (submitted: July 1, 2020)		 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) and tested for correlation.
 
Descriptive Information
Brief Title  ICMJE Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Official Title  ICMJE PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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).
Interventions:
  • Procedure: Computed Tomography
  • Drug: Gallium Ga 68 FAPi-46
  • Procedure: Positron Emission Tomography
  • Radiation: 18F-FDG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2020)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2024
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Limon 310-206-7372 AndreaLimon@mednet.ucla.edu
Contact: Rejah Marie Alano 310-206-7372 RMAlano@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04459273
Other Study ID Numbers  ICMJE 20-000630
NCI-2020-03766 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jonsson Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP