Study of Multiplexed Heptapeptides for Detection of Neopl... | NCT03589443

Studies
Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

NCT03589443

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Aug 5, 2019Actual

Enrollment

27Actual

Phase

Phase 1

Conditions

Barrett Esophagus

Interventions

Multiplexed heptapeptides

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2018Actual

Primary Completion Date

Feb 4, 2019Actual

Completion Date

Feb 4, 2019Actual

First Submitted Date

Jun 21, 2018

First Submission Date that Met QC Criteria

Jul 4, 2018

First Posted Date

Jul 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2019

Last Update Posted Date

Aug 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Danielle Kim Turgeon, Professor of Internal Medicine, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope(SFE) multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel is needed because cancer in the esophagus is genetically heterogeneous. The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiplexed heptapeptides	Experimental	QRH & KSP sprayed onto area of interest and imaged before and after application	Drug: Multiplexed heptapeptides

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multiplexed heptapeptides	Drug	Heptapeptides QRH and KSP	Multiplexed heptapeptides

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validate the binding of the peptides using the SFE	The binding of the fluorescent-labeled peptides (QRH-882260 and KSP-910638G) that bind to EGFR and HER2 using an SFE molecular imaging system (SFE) determined using the tumor-to-background ratio for fluorescence intensities	1 year

Secondary Outcomes

Measure	Description	Time Frame
Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)	One aspect of feasibility will be shown by examining the SNR of the images collected.	1 year
Use of the SFE to detect QRH and KSP via tumor-to-background ratio

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Known or suspected Barrett's esophagus
Scheduled for a clinically-indicated upper endoscopy
Medically cleared for the procedure
Willing and able to sign informed consent

Exclusion Criteria:

Known allergy or negative reaction to the near infrared fluorophores Cy5, li-cor IRDye800CW, or derivatives
One active chemotherapy or radiation treatment
Pregnant or trying to conceive

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Hospital		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D001471	Barrett Esophagus

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided