71 Participants NeededMy employer runs this trial

[18F]FPyQCP PET Imaging for Colorectal Cancer

EP
JM
Overseen ByJamie MacKay, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new imaging drug, [18F]FPyQCP, to determine if it safely and effectively aids in detecting various cancers, including colorectal, gastric, pancreatic, lobular breast, and ovarian cancers. Participants will receive the drug, followed by a PET/CT scan to capture images of the cancer. As a Phase 1/2 study, it focuses on safety and the drug's potential effectiveness. Individuals with a confirmed diagnosis of one of these cancers, whether newly diagnosed, with suspected recurrence, or scheduled for a biopsy or surgery, might be suitable candidates. This trial seeks to understand how the drug works in people and measure its effectiveness in a smaller group, offering participants the chance to contribute to advancements in early-stage cancer detection.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken any radioisotopes or investigational drugs recently, and you should avoid certain contrast agents close to the trial dates.

What prior data suggests that [18F]FPyQCP is safe for PET imaging?

Research shows that [18F]FPyQCP, the substance used in this trial, has been studied for safety and tolerability. In earlier studies, most participants tolerated [18F]FPyQCP well, with no serious side effects reported. This suggests that significant negative reactions were uncommon during the trials.

The studies conducted so far are in the early stages, focusing on safety. These initial studies indicate that [18F]FPyQCP has a good safety record, although more information is still being collected. Participants have not reported any major negative effects related to the treatment, which is promising for safety. However, ongoing research will provide more data to confirm these findings.

Overall, while early results are promising, continued research will offer more detailed safety information.12345

Why are researchers excited about this trial?

[18F]FPyQCP is unique because it uses a new imaging agent specifically designed for PET/CT scans to detect colorectal cancer. Current treatments often focus on surgical, chemotherapeutic, or traditional imaging approaches. Unlike these standard options, [18F]FPyQCP offers a potentially more precise method to visualize cancer, which could lead to better diagnosis and treatment planning. Researchers are excited because this imaging agent might provide clearer images, helping doctors identify tumors more accurately and earlier in the disease progression. This could ultimately improve patient outcomes by tailoring treatments more effectively to individual cases.

What evidence suggests that [18F]FPyQCP PET/CT is effective for detecting colorectal cancer?

Studies have shown that PET/CT scans using the tracer [18F]FPyQCP might help detect certain cancers, including colorectal cancer (CRC). Although specific human data for [18F]FPyQCP remains limited, similar methods like [18F]FDG PET/CT have demonstrated high accuracy in detecting CRC. For instance, one study found that [18F]FDG PET/CT correctly identified CRC 100% of the time and correctly ruled it out 97% of the time. These findings suggest that PET scans with tracers like [18F]FPyQCP, which participants in this trial will receive, could be promising for early cancer detection, potentially aiding in early diagnosis and treatment planning.14678

Who Is on the Research Team?

SR

Steven Rowe, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to under 80 with confirmed or suspected colorectal, stomach, pancreatic, breast (lobular), or ovarian cancer. Participants must be able to give consent, have good physical function, and agree to use contraception if of childbearing potential.

Inclusion Criteria

I am between 18 and 79 years old and able to give consent.
I have been diagnosed with CRC, GC, PDAC, ILC, or EOC.
5. Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to \[18F\]FPyQCP administration.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive [18F]FPyQCP followed by PET/CT imaging

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

42 days

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]FPyQCP

Trial Overview

[18F]FPyQCP is a new imaging agent being tested in PET scans to see how well it detects certain cancers. The study looks at its safety and how much radiation patients receive during the scan.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: [18F]FPyQCP PET/CTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Blue Earth Diagnostics

Lead Sponsor

Trials
43
Recruited
3,100+

Medpace, Inc.

Industry Sponsor

Trials
98
Recruited
30,400+

Dr. August J. Troendle

Medpace, Inc.

Chief Executive Officer since 1992

MD from the University of Maryland, School of Medicine; MBA from Boston University

Dr. Reinilde Heyrman

Medpace, Inc.

Chief Medical Officer since 2017

MD

Citations

Diagnostic Performance of F-18 FDG PET/CT in the Detection ...

Conclusions: F-18 FDG PET/CT showed high diagnostic efficacy in CRC recurrence detection, in correlation with CEA levels, CA 19-9 levels, and ...

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein ...

This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance ...

The Efficacy of 18F-FDG PET/CT in Detecting Colorectal ...

Of the 75 patients, 37 (49%) had colon cancer and 38 (51%) had rectal cancer. A recurrence was eventually diagnosed in 58 of 75 patients (77.3%). The duration ...

Prevalence and malignancy risk of focal colorectal incidental ...

The pooled prevalence of FCIs detected by 18F-FDG-PET or PET/CT was 3.6% (95% confidence interval [95% CI]: 2.6–4.7%). Overall, 1,044 FCIs detected by 18F-FDG- ...

Value of Surveillance 18F-FDG PET/CT in Colorectal Cancer

On case-based analysis, the overall sensitivity, specificity, and accuracy were 100, 97.0, and 97.3% for PET/CT and 85.1, 97.0, and 95.8% for CIS, respectively.

[18F]Fluoromisonidazole PET in rectal cancer - PMC - NIH

The study explores [18F]fluoromisonidazole ([18F]FMISO) positron emission tomography (PET) scans for predicting clinical response in rectal ...

[18F]FPyQCP PET Imaging for Colorectal Cancer

This Phase 1 & 2 medical study run by Blue Earth Diagnostics is evaluating whether [18F]FPyQCP will have tolerable side effects & efficacy ...

18 F-FDG PET/CT-derived parameters for differentiating ...

The aim of this study is to evaluate the ability of 18F-FDG PET/CT-derived parameters to differentiate between colorectal cancer and adenoma. Methods: One ...