GISTPhase 2/3NCT04761172
NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours
A Phase 2/3 study testing Intraoperative near-infrared fluorescence imaging using indocyaninegreen in people with GIST, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST
- What is being tested?
- Intraoperative near-infrared fluorescence imaging using indocyaninegreen
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 2 sitesNetherlands
- Study dates
- 17 Jun 2020to 1 Jun 2022
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
- 18 years
Who cannot join
- History of an allergy or hypersensitivity to sodium iodide, iodine or ICG
- Patients with hyperthyroidism and patients with an autonomous thyroid adenoma
- Patients pregnant or breastfeeding
- Patients with severe renal insufficiency (eGFR <30)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center
Leiden
G. M. Kalisvaart, g.m.kalisvaart@lumc.nl
- Recruiting
Erasmus Medical Center
Rotterdam
H. A. Galema
About this study
Official title: Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study
This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Patients will receive a single dose injection of 10mg ICG at a given moment during the 24 hours prior to surgery or during surgery. The timing of administration will be determined according to a step-up, step-down procedure. Standard of care surgery will be performed and a NIR fluorescence imaging system will be used to record the GIST under fluorescence.
- Conditions
- GIST
- Being tested
- Intraoperative near-infrared fluorescence imaging using indocyaninegreen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative near-infrared fluorescence imaging using indocyaninegreenProcedure or surgery
ICG administration before/during surgery and using near-infrared fluorescence imaging for intra-operative detection and identification of GISTs
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary tumor detection
Tumor detection perceived by the surgeon with and without NIR-imaging
Measured: Intra-operative
Secondary outcomes (2)
Detection of peritoneal tumor depositions
Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging
Measured: Intra-operative
Tumor to background ratio
Pixel intensity ratio on static images
Measured: Through study completion, estimated to be 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start17 Jun 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GISTStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, javanderhage, Leiden University Medical Center
- Investigators
- J. A. van der Hage, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761172
- Sponsor's protocol ID
- NL67828.058.18
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On request anonymized data can be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study
- ClinicalTrials.gov ID
- NCT04761172
- Acronym / sponsor ID
- NL67828.058.18
- Conditions
- GIST
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Feb 2021 (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.
This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Patients will receive a single dose injection of 10mg ICG at a given moment during the 24 hours prior to surgery or during surgery. The timing of administration will be determined according to a step-up, step-down procedure. Standard of care surgery will be performed and a NIR fluorescence imaging system will be used to record the GIST under fluorescence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Open-label pilot study
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
- 18 years
Key exclusion criteria (4 listed)
- History of an allergy or hypersensitivity to sodium iodide, iodine or ICG
- Patients with hyperthyroidism and patients with an autonomous thyroid adenoma
- Patients pregnant or breastfeeding
- Patients with severe renal insufficiency (eGFR <30)
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 |
|---|---|---|
| Intraoperative near-infrared fluorescence imaging using indocyaninegreenICG administration before/during surgery and using near-infrared fluorescence imaging for intra-operative detection and identification of GISTs | Procedure or surgery | – |
Primary outcome
Primary tumor detection
Time frame: Intra-operative
Tumor detection perceived by the surgeon with and without NIR-imaging
2 secondary outcomes
Detection of peritoneal tumor depositions
Time frame: Intra-operative
Tumor to background ratio
Time frame: Through study completion, estimated to be 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No. On request anonymized data can be shared with other researchers
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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.
J. A. van der Hage principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intraoperative near-infrared fluorescence imaging using indocyaninegreen in people with GIST, run by Leiden University Medical Center at 2 sites in Netherlands.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact G. M. Kalisvaart, MD (0715263695, g.m.kalisvaart@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary tumor detection (time frame: Intra-operative). 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 18 Feb 2021.