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NCT Number: NCT04147494

Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi 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 where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. 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. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

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Key information

Conditions

Breast Carcinoma Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Colon Carcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Carcinoma Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Carcinoma Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Carcinoma Kidney Diseases Kidney Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Solid Neoplasm Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Corpus Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ethan Lam

Los Angeles, California, 90095, United States

About this study

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies. The goal is to determine where and to which degree 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulates in normal and cancer tissues.

SECONDARY OBJECTIVES:

I. To evaluate whether 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.

II. To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).

EXPERIMENTAL OBJECTIVE:

III. Assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan, and 18F-fluodeoxyglucose (FDG), if any FDG PET/computed tomography (CT) has been performed as standard-of-care.

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/CT scan over 20-50 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with the following cancer types:
  • Breast cancer
  • Colon cancer
  • Esophageal cancer
  • Gastric cancer
  • Head and Neck cancer
  • Lung cancer
  • Ovarian cancer
  • Pancreatic cancer
  • Renal cancer
  • Uterus cancer
  • Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
  • Patient can provide written informed consent
  • Patient is capable of complying with study procedures
  • 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 18F-FDG 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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT scan

Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT scan, tomography

Gallium Ga 68 FAPi-46

Radiation

Given IV

Other names: 68Ga-FAPi-46, Gallium-68-FAPi-46

Gallium Ga 68-labeled PSMA-11

Radiation

Given IV

Other names: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, Gallium Ga 68 PSMA-11, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68

Positron Emission Tomography

Procedure

Undergo PET/CT scan

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

18F-FDG

Radiation

Given IV

Other names: 18F-fluorodeoxyglucose

Primary outcomes

  1. To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies

    Time frame: 60 minutes after tracer 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-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).

Secondary outcomes

  1. 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation

    Time frame: From date of imaging to date of surgery (range 1-60 days)

    To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of FAP in excised cancer tissue as assessed by immunohistochemistry (IHC).

  2. evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution

    Time frame: up to 2 years

    • To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).

Other outcomes

  1. Additional correlation of biodistribution of standard of care tracer

    Time frame: 60 minutes after tracer injection

    assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Society of Nuclear Medecine and Molecular Imaging

Registry information

Official study title

PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation

Important dates

Study start
2019
Primary completion
2030
Study completion
2031
First posted
Nov 1, 2019
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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