18F-αvβ6-BP for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Julie L. Sutcliffe, Ph.D

Disqualifiers: Pregnancy, Breast-feeding, Life expectancy < 3 mo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiotracer, 18F-αvβ6-BP, to evaluate its effectiveness in helping doctors locate cancer in the body. It targets individuals with cancer in areas such as the breast, colon, lungs, or pancreas. Participants will receive the radiotracer and undergo four PET scans to assess its effectiveness. This trial suits those diagnosed with these cancers who can remain still for up to an hour during each scan. As an Early Phase 1 trial, participants will be among the first to assist researchers in understanding how this new radiotracer functions in people.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that 18F-αvβ6-BP is likely to be safe for humans?

Research has shown that 18F-αvβ6-BP has been tested in healthy individuals. These studies found no harmful side effects. Participants maintained normal vital signs, such as heart rate and blood pressure. Additionally, there was no adverse immune response, indicating that the body's defense system did not react negatively. This suggests that the treatment is well-tolerated in humans, making it a promising option for further research in detecting cancer in the body. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for cancer, which often involves chemotherapy, radiation, or surgery, 18F-αvβ6-BP is a novel imaging agent designed to enhance PET scans. This treatment targets the αvβ6 integrin, a protein frequently overexpressed in various cancers, allowing for more precise tumor detection. Researchers are excited because it could lead to earlier and more accurate cancer diagnosis, improving treatment planning and potentially leading to better outcomes.

What evidence suggests that 18F-αvβ6-BP is effective for cancer imaging?

Research has shown that 18F-αvβ6-BP, the investigational treatment in this trial, holds promise for detecting cancer in the body. This substance acts as a radiotracer, helping to make cancer cells visible during scans. Early studies found it effective in identifying small areas where cancer has spread in patients with lung, colon, breast, or pancreatic cancer. Importantly, the imaging agent did not cause side effects in healthy individuals. These early findings suggest it could enhance cancer detection in patients. ^{1 3 5 6 7}

Who Is on the Research Team?

Julie Sutcliffe

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for people with primary or metastatic breast, colorectal, lung, or pancreatic cancer who can stay still for PET scans and have a good performance status. It's not for those with severe kidney/liver issues, very short life expectancy, pregnant/breastfeeding women, recent investigational drug use, or inability to undergo PET/CT scans.

Inclusion Criteria

I am fully active or have some restrictions but can still care for myself.

I can stay still for up to an hour.

My cancer is in the breast, colorectal, lung, or pancreas.

Exclusion Criteria

Lack of availability for follow-up assessments

I am currently pregnant or breastfeeding.

You are unable to have a PET/CT scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 18F-alphavbeta6-BP intravenously and undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• 18F-αvβ6-BP

Trial Overview The study tests the safety and imaging effectiveness of a radiotracer called 18F-αvβ6-binding-peptide in detecting cancers such as breast, colorectal, lung and pancreatic when used during PET scans.

How Is the Trial Designed?

Group I: 18F-αvβ6-BP Experimental Treatment 1 Intervention

Patients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.

Who Is Running the Clinical Trial?

Julie L. Sutcliffe, Ph.D

Lead Sponsor

Trials

1

Recruited

30+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6377828/

Preclinical development and first-in-human imaging of the ... A first-in-human PET/CT imaging study was performed in patients with metastatic lung, colon, breast or pancreatic cancer. Results: [18F]αvβ6-BP displayed ...

2. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-18-2665/352832/p/Preclinical-Development-and-First-in-Human-Imaging

Preclinical Development and First-in-Human Imaging of the ... Conclusions: The clinical impact of [18F]αvβ6-BP PET imaging demonstrated in this first-in-human study is immediate for a broad spectrum of malignancies. This ...

3. health.ucdavis.edu health.ucdavis.edu/radiology/research/pdfs/symposium-2022/Foster-First-in-Human-Imaging-abstract.PDF

First-in-human imaging and dosimetry of novel integrin [ ... Furthermore, sub-centimeter metastases to these organs were detected. The mean effective dose for [18F]αvβ6-BP was 0.717 mSv/mCi.

4. withpower.com withpower.com/trial/phase-1-tumors-metastatic-to-brain-6-2022-16b2f

[18F]-αvβ6-BP PET Imaging for Lung Cancer In a study with healthy human subjects, [18F]-αvβ6-BP showed no adverse effects, no significant changes in vital signs, and no detectable immune response, ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/keydates/NCT05452005

Fluorine-18-AlphaVBeta6-Binding Peptide Positron ... This study investigates fluorine-18-AlphaVBeta6-BP ([18F]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients ...

6. aacrjournals.org aacrjournals.org/clincancerres/article/25/4/1206/9724/Preclinical-Development-and-First-in-Human-Imaging

Preclinical Development and First-in-Human Imaging of the ... In this respect, our data for [18F]αvβ6-BP indicate a very favorable performance characteristic for identification of small lesions that may be indeterminate on ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/59/supplement_1/50

First-in-human studies of [18F]αvβ6-BP, a PET imaging probe ... First-in-human studies of [18F]αvβ6-BP, a PET imaging probe targeting the cancer-associated integrin αvβ