Sentinel Lymph NodePhase 2/3NCT02850783
SLN in Colon Cancer Using a Multimodal Tracer
A Phase 2/3 study testing 89Zr-nanocoll and Indocyanine Green in people with Sentinel Lymph Node, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
Rationale: Lymph node status is the most important factor in the selection of patients for adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30% stage I/II patients with negative lymph node involvement will develop distant metastases and eventually die from colorectal carcinoma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sentinel Lymph Node
- What is being tested?
- 89Zr-nanocoll and Indocyanine Green
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to Jan 2016
- 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
- Oral and written informed consent
- Age 18 years and older
- Colon cancer (Tis-T1-T2-T3)
- Laparoscopic surgical resection of the tumour
- Regular pre-operative work-up
Who cannot join
- Patients younger than 18 years
- Patients who are legally or mentally incapable or unable to give informed consent
- Gross lymph node involvement
- Invasion of the tumour in surrounding tissue
- Distant metastases
- T4 or metastatic disease discovered during intraoperative staging
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- Contraindications to laparoscopic surgery
- Patients at higher risk for anaphylactic reactions
- Pregnancy
- Recent myocardial infarction
- Allergy for iodine
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081 HV
About this study
Official title: Sentinel Lymph Node Identification in Colon Cancer Using a Radioactive and Fluorescent Tracer; a Feasibility Study
Rationale: Lymph node status is the most important factor in the selection of patients for adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30% stage I/II patients with negative lymph node involvement will develop distant metastases and eventually die from colorectal carcinoma (CRC). Better detection and pathologic staging of the lymph nodes could contribute to a better survival of colon cancer patients. This sentinel lymph node (SLN) procedure aims to identify the first draining lymph node(s) from the primary tumour, which have the highest risk of harbouring metastases. These SLNs can be pathological analysed with several more sensitive histopathologic techniques like immunohistochemical staining (IHC).
Objective: Aim of this study is to investigate if the combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the sentinel lymph node mapping (SLNM) technique in colon cancer by utilizing the radioactive component for preoperative imaging (PET/CT) of the SLNs and the near infrared (NIR) fluorescence component for guidance to the SLNs during surgery.
Read more
Study design: Single centre pilot study Study population: Ten patients with colon cancer (colon ascendens, colon transversum, colon descendens, sigmoid) stage Tis-T1-T2-T3, scheduled for laparoscopic surgical resection of the tumour.
Intervention (if applicable):
The present study will be performed with the radioactive tracer 89Zr-Nanocoll and fluorescent tracer Indocyanine Green (ICG). A colonoscopy will be performed to inject the radioactive tracer 48 hrs before surgery. After injection, patients will undergo the first PET/CT scan. A second PET/CT scan will be performed ± 24 hrs after tracer injection and a third scan just before the surgical procedure; ± 48 hrs after tracer administration. During the surgical procedure ICG diluted in saline and human albumin will be injected at the base of the tumour by colonoscopy. The PET/CT images will be compared with respect to the total number and location of foci and , if visible, lymphatic vessels. During surgery the fluorescent nodes will be marked with a suture in vivo. Thereafter the PET/CT images will be used as a roadmap, to detect SLNs which are not visible with the NIR laparoscope. These nodes will be marked with a suture too. When all radioactive and/ or fluorescent nodes are detected, the specimen will be resected like the conventional method. Ex vivo the specimen will be inspected for fluorescent and/or radioactive nodes not found in vivo. All the identified nodes will be taken out ex vivo and stored separately. The entire specimen will be submitted for pathologic examination. All identified SLNs will be stained with hematoxylin-eosin (H\&E). If the fluorescent or radioactive SLNs are negative after routine H\&E staining, they will be sliced in multiple parts and examined with H\&E staining and immunohistochemistry with the specific marker CAM5.2. Finally, the pathologist uses palpation to identify the remaining non-fluorescent and/ or radioactive lymph nodes. Nodes found by palpation will be screened for fluorescent and/ or radioactive activity too.
The amount of tumour tissue in positive nodes will be evaluated with the Q-prodit; an interactive video morphometry system (Leica, Cambridge, UK).
Main study parameters/endpoints: Main study parameter is the identification rate of SLN mapping with preoperative PET/CT scans combined with intraoperative near-infrared (NIR) fluorescence imaging in patients with colon carcinoma. Thereby biodistribution and kinetics of 89Zr-Nanocoll have to be considered as primary study parameter. Secondary endpoints are the number and localization of the SLNs and optimal tracer volume.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participating patients will receive conventional resection of the tumour and follow-up according to normal standards in our hospital. The main goal of this study is to optimize the SLN mapping technique in colon cancer. If the investigators are able to identify the true SLN this could lead to better staging and survival of patients with this type of cancer. . Because of the colonoscopy ± 48 hrs before surgery, patients stay in the hospital will be prolonged with one day. The additional risks of exposure to radiation for participating patients are calculated and can be considered as negligible.
- Conditions
- Sentinel Lymph Node
- Being tested
- 89Zr-nanocoll and Indocyanine Green
- Keywords
- colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-nanocoll and Indocyanine GreenProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SLN identification with 89-zirconium-nanocoll | Experimental | Submucosal injection of 2.5 mBq, 0.4 ml 89-Zirconium-Nanocoll and subsequently SLN identification Receives: Procedure: 89Zr-nanocoll and Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification rate of SLNM with preoperative PET/CT imaging and intraoperative NIR fluorescence imaging in patients with colon carcinoma.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph NodeStudies 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 2/3
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjolein Ankersmit, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850783
- Sponsor's protocol ID
- NL47648.029.14
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Identification in Colon Cancer Using a Radioactive and Fluorescent Tracer; a Feasibility Study
- ClinicalTrials.gov ID
- NCT02850783
- Acronym / sponsor ID
- NL47648.029.14
- Conditions
- Sentinel Lymph Node
- Keywords
- colon cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
Rationale: Lymph node status is the most important factor in the selection of patients for adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30% stage I/II patients with negative lymph node involvement will develop distant metastases and eventually die from colorectal carcinoma (CRC). Better detection and pathologic staging of the lymph nodes could contribute to a better survival of colon cancer patients. This sentinel lymph node (SLN) procedure aims to identify the first draining lymph node(s) from the primary tumour, which have the highest risk of harbouring metastases. These SLNs can be pathological analysed with several more sensitive histopathologic techniques like immunohistochemical staining (IHC).
Objective: Aim of this study is to investigate if the combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the sentinel lymph node mapping (SLNM) technique in colon cancer by utilizing the radioactive component for preoperative imaging (PET/CT) of the SLNs and the near infrared (NIR) fluorescence component for guidance to the SLNs during surgery.
Study design: Single centre pilot study Study population: Ten patients with colon cancer (colon ascendens, colon transversum, colon descendens, sigmoid) stage Tis-T1-T2-T3, scheduled for laparoscopic surgical resection of the tumour.
Intervention (if applicable):
The present study will be performed with the radioactive tracer 89Zr-Nanocoll and fluorescent tracer Indocyanine Green (ICG). A colonoscopy will be performed to inject the radioactive tracer 48 hrs before surgery. After injection, patients will undergo the first PET/CT scan. A second PET/CT scan will be performed ± 24 hrs after tracer injection and a third scan just before the surgical procedure; ± 48 hrs after tracer administration. During the surgical procedure ICG diluted in saline and human albumin will be injected at the base of the tumour by colonoscopy. The PET/CT images will be compared with respect to the total number and location of foci and , if visible, lymphatic vessels. During surgery the fluorescent nodes will be marked with a suture in vivo. Thereafter the PET/CT images will be used as a roadmap, to detect SLNs which are not visible with the NIR laparoscope. These nodes will be marked with a suture too. When all radioactive and/ or fluorescent nodes are detected, the specimen will be resected like the conventional method. Ex vivo the specimen will be inspected for fluorescent and/or radioactive nodes not found in vivo. All the identified nodes will be taken out ex vivo and stored separately. The entire specimen will be submitted for pathologic examination. All identified SLNs will be stained with hematoxylin-eosin (H\&E). If the fluorescent or radioactive SLNs are negative after routine H\&E staining, they will be sliced in multiple parts and examined with H\&E staining and immunohistochemistry with the specific marker CAM5.2. Finally, the pathologist uses palpation to identify the remaining non-fluorescent and/ or radioactive lymph nodes. Nodes found by palpation will be screened for fluorescent and/ or radioactive activity too.
The amount of tumour tissue in positive nodes will be evaluated with the Q-prodit; an interactive video morphometry system (Leica, Cambridge, UK).
Main study parameters/endpoints: Main study parameter is the identification rate of SLN mapping with preoperative PET/CT scans combined with intraoperative near-infrared (NIR) fluorescence imaging in patients with colon carcinoma. Thereby biodistribution and kinetics of 89Zr-Nanocoll have to be considered as primary study parameter. Secondary endpoints are the number and localization of the SLNs and optimal tracer volume.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participating patients will receive conventional resection of the tumour and follow-up according to normal standards in our hospital. The main goal of this study is to optimize the SLN mapping technique in colon cancer. If the investigators are able to identify the true SLN this could lead to better staging and survival of patients with this type of cancer. . Because of the colonoscopy ± 48 hrs before surgery, patients stay in the hospital will be prolonged with one day. The additional risks of exposure to radiation for participating patients are calculated and can be considered as negligible.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLN identification with 89-zirconium-nanocoll | Experimental | Procedure: 89Zr-nanocoll and Indocyanine GreenSubmucosal injection of 2.5 mBq, 0.4 ml 89-Zirconium-Nanocoll and subsequently SLN identification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Oral and written informed consent
- Age 18 years and older
- Colon cancer (Tis-T1-T2-T3)
- Laparoscopic surgical resection of the tumour
- Regular pre-operative work-up
Key exclusion criteria (12 listed)
- Patients younger than 18 years
- Patients who are legally or mentally incapable or unable to give informed consent
- Gross lymph node involvement
- Invasion of the tumour in surrounding tissue
- Distant metastases
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 |
|---|---|---|
| 89Zr-nanocoll and Indocyanine Green | Procedure or surgery | SLN identification with 89-zirconium-nanocoll |
Primary outcome
Identification rate of SLNM with preoperative PET/CT imaging and intraoperative NIR fluorescence imaging in patients with colon carcinoma.
Time frame: one 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 1 Aug 2016.
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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 2/3 study testing 89Zr-nanocoll and Indocyanine Green in people with Sentinel Lymph Node, run by VU University of Amsterdam at 1 site 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 5 inclusion and 12 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 1 Aug 2016. 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 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?
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?
Identification rate of SLNM with preoperative PET/CT imaging and intraoperative NIR fluorescence imaging in patients with colon carcinoma. (time frame: one 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 1 Aug 2016.