CholangiocarcinomaPhase 1NCT03438435
Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
A Phase 1 study testing QRH-882260 Heptapeptide in people with Cholangiocarcinoma, run by D. Kim Turgeon, MD at 1 site in United States.
Trial summary
Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence peptide. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- QRH-882260 Heptapeptide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 21 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged 18 to 65
- Scheduled for outpatient ERCP
- Understands English and is interested in participating
- Provides signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
Who cannot join
- Sleep apnea or respiratory problems
- Pregnant or trying to conceive
- Known allergy or negative reaction to components of the study product(s)
- On active chemotherapy or radiation treatment
- Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence peptide. The images will be recorded and analyzed for relative fluorescence pattern and intensity and correlated to patient diagnosis and clinical outcomes.
Read the detailed description
A Phase 1b study of the safety and efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the bile duct is proposed. The study will test the safety and efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically indicated ERCP for the evaluation of biliary disorders.
This is a pilot study of a single study group at a single center. The investigators intend to enroll 12 evaluable subjects. Expected enrollment is one subject every 1 month, so the study should take 12 to 24 months to complete. The expected duration of each subject's participation is 2 to 7 days.
Subjects will be recruited around their standard of care procedure. The endoscopists performing study procedures are all credentialed to do these procedures at the UWMC Digestive Health Center.
ERCP will proceed per UWMC standard of care. The endoscopists performing the procedure will evaluate the potential risk (if any) for the subject to continue with the study procedure. Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be administered to the site of interest through a catheter in the standard endoscope. Five minutes after QRH-882260 Heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. Pictures with reflection-light and fluorescence will be taken with the SFE based molecular imaging mini-cholangioscope (MC) inserted via the instrument channel of the standard endoscope before the QRH-882260 Heptapeptide application, immediately after application and then again after the QRH-882260 Heptapeptide is rinsed.
The area of interest identified will be biopsied at the discretion of the endoscopist per clinical care. Any specimens taken will be for clinical care only and will be sent for routine histology per UWMC standard of care.
- Conditions
- Cholangiocarcinoma
- Being tested
- QRH-882260 Heptapeptide
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRH-882260 HeptapeptideDrug
Imaging agent
| Study group | Role | What they receive |
|---|---|---|
| QRH-882260 Heptapeptide | Experimental | Five mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide Receives: Drug: QRH-882260 Heptapeptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy
Measured: 30 months
Secondary outcomes (1)
Evaluation of imaging content based on the clinical diagnosis
Images taken during the procedure will be compared to the clinical diagnosis for the subject for correlation
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start22 Apr 2019
- Primary completion21 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- D. Kim Turgeon, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Michael Saunders, MD, University of Washington
- Investigators
- Michael Saunders, MD, Principal investigator, Clinical Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438435
- Sponsor's protocol ID
- HUM00130597
- Status last verified
- Dec 2020
- First submitted
- 30 Jan 2018
- Last updated
- 2 Dec 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
- ClinicalTrials.gov ID
- NCT03438435
- Acronym / sponsor ID
- HUM00130597
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- D. Kim Turgeon, MDUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 19 Feb 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.
Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence peptide. The images will be recorded and analyzed for relative fluorescence pattern and intensity and correlated to patient diagnosis and clinical outcomes.
Detailed description
A Phase 1b study of the safety and efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the bile duct is proposed. The study will test the safety and efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically indicated ERCP for the evaluation of biliary disorders.
This is a pilot study of a single study group at a single center. The investigators intend to enroll 12 evaluable subjects. Expected enrollment is one subject every 1 month, so the study should take 12 to 24 months to complete. The expected duration of each subject's participation is 2 to 7 days.
Subjects will be recruited around their standard of care procedure. The endoscopists performing study procedures are all credentialed to do these procedures at the UWMC Digestive Health Center.
ERCP will proceed per UWMC standard of care. The endoscopists performing the procedure will evaluate the potential risk (if any) for the subject to continue with the study procedure. Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be administered to the site of interest through a catheter in the standard endoscope. Five minutes after QRH-882260 Heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. Pictures with reflection-light and fluorescence will be taken with the SFE based molecular imaging mini-cholangioscope (MC) inserted via the instrument channel of the standard endoscope before the QRH-882260 Heptapeptide application, immediately after application and then again after the QRH-882260 Heptapeptide is rinsed.
The area of interest identified will be biopsied at the discretion of the endoscopist per clinical care. Any specimens taken will be for clinical care only and will be sent for routine histology per UWMC standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QRH-882260 Heptapeptide | Experimental | Drug: QRH-882260 HeptapeptideFive mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged 18 to 65
- Scheduled for outpatient ERCP
- Understands English and is interested in participating
- Provides signed and dated informed consent form
Key exclusion criteria (5 listed)
- Sleep apnea or respiratory problems
- Pregnant or trying to conceive
- Known allergy or negative reaction to components of the study product(s)
- On active chemotherapy or radiation treatment
- Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
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 |
|---|---|---|
| QRH-882260 HeptapeptideImaging agent | Drug | QRH-882260 Heptapeptide |
Primary outcome
Treatment-related Adverse Events
Time frame: 30 months
Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy
1 secondary outcome
Evaluation of imaging content based on the clinical diagnosis
Time frame: 30 months
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 2 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Michael Saunders, MD principal investigator
Clinical Professor of Medicine
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 QRH-882260 Heptapeptide in people with Cholangiocarcinoma, run by D. Kim Turgeon, MD 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 6 inclusion and 5 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 2 Dec 2020. 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?
Treatment-related Adverse Events (time frame: 30 months). 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 2 Dec 2020.