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

  • STATUS
    Recruiting
  • End date
    Oct 17, 2031
  • participants needed
    30
  • sponsor
    Jonsson Comprehensive Cancer Center
Updated on 14 April 2021
ct scan
cancer surgery
cancer
breast cancer
lung cancer
x-rays
metastasis
esophageal cancer
colon cancer
primary tumor
positron emission tomography
gastric cancer
ovarian cancer
head and neck cancer
pet/ct scan
esophagus cancer
kidney cancer
neck cancer
pancreatic cancers
cancer, ovarian
cancer of the ovary
gallium ga 68-labeled psma-11
lung carcinoma

Summary

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 a second PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients can decide to have only the FAPI 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. 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.

Description

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. As an exploratory study aim, will also 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. 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).

Details
Condition Pancreatic Cancer, Ductal Carcinoma In Situ, Pulmonary Disease, urinary tract neoplasm, Ovarian disorder, Colorectal Cancer, Malignant neoplasm of kidney, Nephropathy, Disorder of uterus NOS, Uterine Cancer, Pancreatic disorder, Breast Cancer, Ovarian Cancer, Esophageal Diseases, Esophageal Cancer, Malignant neoplasm of colon, Renal Cell Carcinoma, Lung Neoplasm, Neoplasm of unspecified nature of digestive system, Gastropathy, Gastric Cancer, Bronchial Neoplasm, head and neck cancer, Stomach Discomfort, Pancreatic Disorders, Kidney Disease (Pediatric), Colon Cancer Screening, Solid Tumors, Colon cancer; rectal cancer, Ovarian Function, Esophageal Carcinoma, Solid Neoplasm, Breast Cancer Diagnosis, Uterine Corpus Cancer, Gastric Carcinoma, Head and Neck Carcinoma, Epithelial Ovarian Carcinoma, Recurrent Ovarian Cancer, Carcinoma of the Head and Neck, Solid Tumour, Ductal Carcinoma In Situ (DCIS), Islet Ce417ll Cancer, Kidney Cancer, Lung Cancer, Colon Cancer, Esophageal Disorders, Kidney Disease, Lung Disease, Stomach Cancer, Uterine Disorders, Renal Cell Cancer, Renal Cancer, Digestive System Neoplasms, Urologic Cancer, breast carcinoma, ovarian carcinoma, ovarian epithelial carcinoma, carcinoma of the ovary, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, colon carcinoma, cancer of the pancreas, cancer of the esophagus, oesophageal carcinoma, carcinoma lung, lung carcinoma
Treatment computed tomography, positron emission tomography, Gallium Ga 68-labeled PSMA-11, 68GA-PSMA, 68GA-FAPi, Gallium Ga 68 FAPi-46
Clinical Study IdentifierNCT04147494
SponsorJonsson Comprehensive Cancer Center
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

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
Patient has underlying disease which based on the judgment of the investigator, might interfere with the collection of high quality data
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