Colon CancerMINIMALNCT03779009
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
A study testing ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll) in people with Colon Cancer and Sentinel Lymph Node, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Sentinel Lymph Node
- What is being tested?
- ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2018to 31 Dec 2025
- Phase
- Interventional
- 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
- Tumor type: proven adenocarcinoma of the colon
- Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer
- Locally resectable disease
- Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
- Laboratory data
- Serum creatinine ≤ 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2
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- Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease
- Platelet count > 100,000/µl
- Hemoglobin > 9g/dl
- Neutrophil granulocytes > 1,500/ml
- International Normalized Ratio (INR) ≤ 2
- Absence of alcohol and/or drug abuse
- No inclusion in other clinical trials interfering with the study protocol
- No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy
- Absence of any severe organ insufficiency
- No pregnancy or breast feeding
- Adequate contraception in fertile patients
- Written informed consent
Who cannot join
- Node positive and/or metastatic disease
- Locally unresectable disease
- Medically unfit patients (Karnofsky index < 70%)
- Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Wim Ceelen, +32(0)93326251, wim.ceelen@ugent.be
Sarah Cosyns
About this study
The project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).
- Conditions
- Colon Cancer, Sentinel Lymph Node
- Being tested
- ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)Other
Under laparoscopic control, 2.0 ml of ICG-nanocoll will be injected into the subserosa at four quadrants around the tumor. Directly after injection, near infrared (NIR) fluorescence images (Olympus, Tokyo, Japan) will be acquired. SLNs will be identified and marked.
| Study group | Role | What they receive |
|---|---|---|
| Tracer injection | Experimental | Not described Receives: Other: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)
All LN in the resection specimen will be collected, mapped, and labeled. The SLN is defined as fluorescent hotspot that appears after injection of the tracer. Standard H\&E staining will be performed on LN sections and all mapped LN (including the SLN) will be analyzed for their tumor status.
Measured: up to 1 month after surgery
Secondary outcomes (1)
Immunological markers
Single cell suspensions will be prepared from all LN (including the SLNs) and the primary tumor. Cell suspensions will be analyzed for cytotoxic CD8+ CD45RO+T cells, CD4+ T helper cells, dendritic cell subsets (DC), natural killer (NK) cells, tumor-associated macrophages (TAM), and myeloid-derived suppressor cells (MDSCs) by multicolor fluorescence-activated cell sorting (FACS)-based immuno-panels. FACS is technique to detect and measure physical and chemical characteristics of a population of cells and provides quantifiable data.
Measured: up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779009
- Sponsor's protocol ID
- EC/2017/1356
- Acronym
- MINIMAL
- Status last verified
- Sep 2024
- First submitted
- 12 Dec 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
- ClinicalTrials.gov ID
- NCT03779009
- Acronym / sponsor ID
- MINIMAL / EC/2017/1356
- Conditions
- Colon Cancer, Sentinel Lymph Node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Dec 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 project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracer injection | Experimental | Other: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Tumor type: proven adenocarcinoma of the colon
- Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer
- Locally resectable disease
- Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
- Laboratory data
Key exclusion criteria (4 listed)
- Node positive and/or metastatic disease
- Locally unresectable disease
- Medically unfit patients (Karnofsky index < 70%)
- Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)
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 |
|---|---|---|
| ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)Under laparoscopic control, 2.0 ml of ICG-nanocoll will be injected into the subserosa at four quadrants around the tumor. Directly after injection, near infrared (NIR) fluorescence images (Olympus, Tokyo, Japan) will be acquired. SLNs will be identified and marked. | Other | Tracer injection |
Primary outcome
Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)
Time frame: up to 1 month after surgery
All LN in the resection specimen will be collected, mapped, and labeled. The SLN is defined as fluorescent hotspot that appears after injection of the tracer. Standard H\&E staining will be performed on LN sections and all mapped LN (including the SLN) will be analyzed for their tumor status.
1 secondary outcome
Immunological markers
Time frame: up to 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll) in people with Colon Cancer and Sentinel Lymph Node, run by University Hospital, Ghent at 1 site in Belgium.
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 18 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 19 Sep 2024. 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 Belgium. 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.
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 Wim Ceelen (+32(0)93326251, wim.ceelen@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's) (time frame: up to 1 month after surgery). 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 19 Sep 2024.