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[18F]-αvβ6-BP PET Imaging for Lung Cancer

Phase 1

Recruiting

Led By Julie L. Sutcliffe, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women age >18 yrs

Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to six months

Awards & highlights

Study Summary

This trial is testing a new imaging agent, [18F]-αvβ6-BP, to see if it can help detect brain metastases in patients with NSCLC.

Who is the study for?

This trial is for men and women over 18 with Non-Small Cell Lung Cancer (NSCLC) that has spread to the brain. They should be planning more cancer treatment, have a life expectancy of at least 3 months, and able to undergo PET/CT scans. Pregnant or breastfeeding individuals, prisoners, those with other cancers, or who exceed weight limits for scanning (>350lbs) cannot participate.Check my eligibility

What is being tested?

[18F]-αvβ6-BP is being tested as a new imaging agent in PET/CT scans for patients with NSCLC and brain metastases. The study aims to see if this agent can better assess the disease compared to current methods.See study design

What are the potential side effects?

The side effects are not explicitly listed but may include discomfort from remaining still during the scan and potential reactions to the [18F]-αvβ6-BP imaging agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have available samples of my tumor for testing.

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My lung cancer has spread to my brain.

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I am scheduled for more cancer treatment and then imaging to check its effects.

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I can perform all self-care but cannot work.

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My kidney function is normal or only mildly reduced.

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I can stay still for up to an hour for scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bronchial Provocation Tests

Secondary outcome measures

Bronchial Provocation Tests

Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment

Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental [18F]-αvβ6-BPExperimental Treatment1 Intervention

Patients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

910 Previous Clinical Trials

4,706,971 Total Patients Enrolled

United States Department of DefenseFED

861 Previous Clinical Trials

227,174 Total Patients Enrolled

Julie L. Sutcliffe, PhDPrincipal InvestigatorThe Regents of the University of California (Davis)

Media Library

[18F]-αvβ6-BP Clinical Trial Eligibility Overview. Trial Name: NCT05452005 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Experimental [18F]-αvβ6-BP

Non-Small Cell Lung Cancer Clinical Trial 2023: [18F]-αvβ6-BP Highlights & Side Effects. Trial Name: NCT05452005 — Phase 1

[18F]-αvβ6-BP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452005 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment slots available for this medical trial?

"Affirmative. Clinicaltrials.gov displays that this research endeavor, which was first published on September 13th 2022, is recruiting participants presently. There are 20 slots open at one medical centre for volunteers to join the study."

Answered by AI

What is the scope of participant recruitment for this clinical research endeavor?

"Indeed, the online data hosted on clinicaltrials.gov attests to this medical experiment's recruitment effort that began on September 13th 2022 and was recently updated on September 19th 2022. This trial is seeking 20 participants from one site."

Answered by AI

Does the US Food and Drug Administration authorize the use of [18F]-αvβ6-BP?

"As this is an early stage trial, evidence of [18F]-αvβ6-BP's safety and efficacy are sparse. As such, our team at Power have assigned a score of 1 to the medication in terms of it's perceived security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer

Julie L. Sutcliffe, Ph.D 2022. "Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05452005.