Barrett EsophagusPhase 1NCT03589443
Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
A Phase 1 study testing Multiplexed heptapeptides in people with Barrett Esophagus, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Multiplexed heptapeptides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 4 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
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.
- Conditions
- Barrett Esophagus
- Being tested
- Multiplexed heptapeptides
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplexed heptapeptidesDrug
Heptapeptides QRH and KSP
| Study group | Role | What they receive |
|---|---|---|
| Multiplexed heptapeptides | Experimental | QRH \& KSP sprayed onto area of interest and imaged before and after application Receives: Drug: Multiplexed heptapeptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
Use of the SFE to detect QRH and KSP via tumor-to-background ratio
One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected.
Measured: 1 year
Use of the SFE to detect QRH and KSP via contrast
One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start10 May 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Kim Turgeon, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589443
- Sponsor's protocol ID
- HUM00137993
- Status last verified
- Aug 2019
- First submitted
- 21 Jun 2018
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
- ClinicalTrials.gov ID
- NCT03589443
- Acronym / sponsor ID
- HUM00137993
- Conditions
- Barrett Esophagus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiplexed heptapeptides | Experimental | Drug: Multiplexed heptapeptidesQRH \& KSP sprayed onto area of interest and imaged before and after application |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplexed heptapeptidesHeptapeptides QRH and KSP | Drug | Multiplexed heptapeptides |
Primary outcome
Validate the binding of the peptides using the SFE
Time frame: 1 year
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
3 secondary outcomes
Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)
Time frame: 1 year
Use of the SFE to detect QRH and KSP via tumor-to-background ratio
Time frame: 1 year
Use of the SFE to detect QRH and KSP via contrast
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multiplexed heptapeptides in people with Barrett Esophagus, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the binding of the peptides using the SFE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.