Barrett EsophagusPhase 1NCT03852576
Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
A Phase 1 study testing KSP/QRH dimer 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) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use… 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?
- KSP/QRH dimer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to 18 Nov 2020
- 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
- Has known or suspected Barrett's esophagus
- Scheduled for a clinically-indicated, upper endoscopy
- Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
- Age 18 to 100 years
- Willing and able to sign informed consent
Who cannot join
- Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
- Subjects on active chemotherapy or radiation treatment
- Pregnant or trying to conceive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer 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) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.
- Conditions
- Barrett Esophagus
- Being tested
- KSP/QRH dimer
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSP/QRH dimerDrug
KSP-QRH-E3-IRDye800 (Peptide 919288G)
| Study group | Role | What they receive |
|---|---|---|
| Esophagus sprayed with KSP/QRH dimer | Experimental | Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe Receives: Drug: KSP/QRH dimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding of KSP/QRH dimer to EGFR and HER2
Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background
Measured: During and immediately after procedure, generally no more than 2 hours
SFE ability to detect dimer by SNR
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR)
Measured: During and immediately after procedure, generally no more than 2 hours
SFE ability to detect dimer by fluorescence T/B ratio
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using fluorescence tumor-to-background (T/B) ratio
Measured: During and immediately after procedure, generally no more than 2 hours
SFE ability to detect dimer with contrast
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast
Measured: During and immediately after procedure, generally no more than 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start9 May 2019
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
Why it stopped: Study had to be terminated for lack of dimer and inability to produce more at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 38 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
- Investigators
- Danielle K Turgeon, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852576
- Sponsor's protocol ID
- HUM00158121
- Status last verified
- Nov 2022
- First submitted
- 20 Feb 2019
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chen J, Jiang Y, Chang TS, Rubenstein JH, Kwon RS, Wamsteker EJ, Prabhu A, Zhao L, Appelman HD, Owens SR, Beer DG, Turgeon DK, Seibel EJ, Wang TD. Detection of Barrett's neoplasia with a near-infrared fluorescent heterodimeric peptide. Endoscopy. 2022 Dec;54(12):1198-1204. doi: 10.1055/a-1801-2406. Epub 2022 Mar 17.
PubMed 35299273
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus
- ClinicalTrials.gov ID
- NCT03852576
- Acronym / sponsor ID
- HUM00158121
- Conditions
- Barrett Esophagus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study had to be terminated for lack of dimer and inability to produce more at this time.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 25 Feb 2019 (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) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). 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 |
|---|---|---|
| Esophagus sprayed with KSP/QRH dimer | Experimental | Drug: KSP/QRH dimerArea of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has known or suspected Barrett's esophagus
- Scheduled for a clinically-indicated, upper endoscopy
- Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
- Age 18 to 100 years
- Willing and able to sign informed consent
Key exclusion criteria (3 listed)
- Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
- Subjects on 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 |
|---|---|---|
| KSP/QRH dimerKSP-QRH-E3-IRDye800 (Peptide 919288G) | Drug | Esophagus sprayed with KSP/QRH dimer |
Primary outcome
Binding of KSP/QRH dimer to EGFR and HER2
Time frame: During and immediately after procedure, generally no more than 2 hours
Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background
SFE ability to detect dimer by SNR
Time frame: During and immediately after procedure, generally no more than 2 hours
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR)
SFE ability to detect dimer by fluorescence T/B ratio
Time frame: During and immediately after procedure, generally no more than 2 hours
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using fluorescence tumor-to-background (T/B) ratio
SFE ability to detect dimer with contrast
Time frame: During and immediately after procedure, generally no more than 2 hours
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast
Results and safety
The study was stopped early (reason given: Study had to be terminated for lack of dimer and inability to produce more at this time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 35299273Chen J, Jiang Y, Chang TS, Rubenstein JH, Kwon RS, Wamsteker EJ, Prabhu A, Zhao L, Appelman HD, Owens SR, Beer DG, Turgeon DK, Seibel EJ, Wang TD. Detection of Barrett's neoplasia with a near-infrared fluorescent heterodimeric peptide. Endoscopy. 2022 Dec;54(12):1198-1204. doi: 10.1055/a-1801-2406. Epub 2022 Mar 17.
- Individual participant dataSharing planned: Yes
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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.
Danielle K Turgeon, MD principal investigator
University of Michigan
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 KSP/QRH dimer 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 5 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: stopped early, as of the sponsor's last update on 22 Nov 2022. 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 was stopped early (reason given: Study had to be terminated for lack of dimer and inability to produce more at this time.). Results are not available in the source record.
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?
Binding of KSP/QRH dimer to EGFR and HER2 (time frame: During and immediately after procedure, generally no more than 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852576, which also lists 1 linked publication.
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 22 Nov 2022.