Study on [18F]FPyQCP PET Imaging for Detecting Certain Types of Cancer

Sponsor: Blue Earth Diagnostics

Sponsor score: 0

ClinicalTrials ID:NCT07432633

This clinical trial is testing a new imaging method using [18F]FPyQCP to help detect various cancers, including colorectal, gastric, pancreatic, breast, and ovarian cancers. The study aims to evaluate the safety and effectiveness of this imaging technique.

Patient Parameters

Program Overview

The purpose of this study is to test a new imaging method called [18F]FPyQCP PET, which may help in detecting certain types of cancer, such as colorectal, gastric, pancreatic, breast, and ovarian cancers. The study will assess how safe this imaging method is, how the radiation is distributed in the body, and how well it can identify these cancers.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 to 79 years old and able to give informed consent.
  • Have a performance status score of 2 or less, indicating good overall health.
  • Diagnosed with colorectal, gastric, pancreatic, breast, or ovarian cancer, confirmed by medical tests.
  • Women who can become pregnant must have a negative pregnancy test before the imaging procedure and agree to use effective birth control during the study.
  • Men who are sexually active with women who can become pregnant must also agree to use effective birth control.
  • For Cohort A: Must have stage I-III cancer or stage IV with limited metastases (5 or fewer) as shown by recent imaging.
  • For Cohort B: Must have recent imaging available for review, including a CT scan of the abdomen and pelvis.
  • Must be either newly diagnosed with at least stage IIB cancer, have a biopsy sample available, or have completed initial therapy with a scheduled biopsy or surgery.

Exclusion Criteria

  • Have received any radioactive substance recently.
  • Have taken any investigational medication recently.
  • Have used any contrast agent recently.
  • Have severe claustrophobia or panic attacks in confined spaces.
  • Have an allergy to [18F]FPyQCP or its ingredients.
  • Have any medical condition that might affect the study results.
  • Have an autoimmune or inflammatory disorder that could affect imaging results, except those related to the cancer being studied.
  • Have had radiation treatment to the abdomen, pelvis, or breast in the last 3 months.
  • Have any implanted foreign material that could affect imaging results.
  • Have significant kidney or liver problems.
  • Are breastfeeding, unless willing to pump and discard breast milk for 24 hours after the imaging procedure.
  • For Cohort A: No history of any other cancer.

Locations

FACILITYZIPCITYSTATE
University of Texas Southwestern Medical Center75390DallasTexas

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