What is [18F]FPyQCP studying for colorectal and other cancers?

[18F]FPyQCP is being studied to see how safe it is, its radiation exposure, and how well it detects various cancers including colorectal, gastric, pancreatic, breast, and ovarian cancers. The research aims to improve imaging diagnosis for these cancers under the sponsorship of Blue Earth Diagnostics. Participants will help evaluate this new imaging agent's performance in detecting cancer.

Who may be eligible for this cancer clinical trial?

Adults aged 18 to under 80 with confirmed or suspected colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast, or epithelial ovarian cancer may be eligible. Participants must be able to consent and have a good performance status. Women of childbearing potential must test negative for pregnancy and use contraception. Please review eligibility criteria for more details.

Is there any cost to participate in this cancer clinical trial?

Study-related care, including the imaging agent and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 80Years

All Genders

ID07432633

A Phase 12 Study of 18FFPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Led by Blue Earth Diagnostics · Updated on 2026-03-27

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a new imaging agent called 18FFPyQCP in a Phase 12 trial to evaluate its safety, radiation exposure, and how well it detects several cancers colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of 18FFPyQCP followed by a positron emission tomography PETcomputed tomography CT scan during a designated imaging visit. The study includes two groups Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well 18FFPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.

CONDITIONS

Brief Title

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants provide informed consent and agree to follow the study protocol
Aged 18 years or older and younger than 80 years
Eastern Cooperative Oncology Group performance status of 2 or less
Diagnosed with colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, or epithelial ovarian cancer (confirmed or suspected)
Women of childbearing potential must have negative pregnancy tests at screening and before imaging
Women of childbearing potential and sexually active men agree to use effective contraception during the study
Cohort A: Stage I-III cancer or stage IV with five or fewer known metastases confirmed by imaging within 8 weeks before imaging
Cohort B: Recent conventional imaging including contrast-enhanced CT of abdomen and pelvis within 8 weeks before screening and 24 hours before imaging
Treatment-na�ve with at least stage IIB disease or post-neoadjuvant therapy with scheduled biopsy or surgery within 42 days, or suspected recurrence after therapy

You will not qualify if you...

Received any radioisotope within five physical half-lives prior to imaging
Received any other investigational medicinal product within two weeks or five half-lives before imaging
Recent use of contrast agents within 24 hours (intravenous) or 5 days (oral) before imaging day
History of severe claustrophobia or panic attacks in confined spaces
Known allergy to [18F]FPyQCP or its components
Medical conditions or history that may affect data reliability or study completion
Autoimmune or inflammatory disorders that could interfere with imaging interpretation
Abdomino-pelvic or breast radiation therapy within the last 3 months
Current implanted foreign materials that may affect imaging
Significant kidney or liver impairment
Breastfeeding women unless willing to discard milk for at least 24 hours after imaging
Cohort A: Prior history of any other cancer not allowed during screening period

Research Team

Jamie MacKay, MD, PhD

Evgenia Perkins

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