Colorectal CancerPhase 2FOCUS GREENNCT05965817
Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN
A Phase 2 study testing SGM-101 op top of ICG in people with Colorectal Cancer and Liver Metastasis Colon Cancer, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This will be the first trial testing the feasibility of working simultaneously with the two fluorescent dyes ICG and SGM-101 in 10 patients with colorectal metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastasis Colon Cancer, Image
- What is being tested?
- SGM-101 op top of ICG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to 1 May 2025
- Phase
- Phase 2
- 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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Diagnosed with liver metastases of colorectal origin for which surgical resection is proposed and meet at least one of the following criteria:
- Scheduled for surgical resection of >3 CRLM or;
- completed neo-adjuvant therapy, of which the last course was completed within 3 months before surgery or;
- Scheduled for surgery because of a locally recurrent liver metastasis.
- ≥18 years old.
- Willing and capable to give informed consent before study specific procedures
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients with contraindications for SGM-101
- History of any anaphylactic shock;
- Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
- Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
- Previous administration of SGM-101
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- Patients with contraindications for Indocyanine green:
- Allergy for shells and/or clamps
- Hyperthyroidism
- Known allergy for ICG
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333ZA
Mats Warmerdam, Msc, +31715298420, m.i.warmerdam@lumc.nl
About this study
This will be the first trial testing the feasibility of working simultaneously with the two fluorescent dyes ICG and SGM-101 in 10 patients with colorectal metastases.
Read the detailed description
25-30% of patients with colorectal cancer develop colorectal liver metastases (CRLM). Cornerstone for optimal survival is achieving radical surgical resections of all metastases . To assist the surgeon in achieving this, the use of intra-operative ICG for fluorescent tumour delineation has widely been adopted as standard of care. Multiple international trials have demonstrated that the use of ICG increases the rate of radical resections and result in the detection of additional malignant lesions invisible to the naked eye. However, the rate of false positives is still high and although it has increased the number of radical resections, even in a minimal invasive cohort the unintended R1 rate is still as much as 8%. Therefore, there is a need of an additional real-time intra-operative tool to detect R1 resections, especially in patients with a priori high risk for R1. To illustrate, in a large shared database of the Erasmus University Medical Center was found that patients that either received neoadjuvant chemotherapy, underwent a resection for >3 CRLM or patients that had a locally recurrent liver metastasis were independently associated with high R1 rates, ranging between 23-29%. Therefore, here is proposed the addition of SGM-101, a tumour targeted (carcinoembryonic antigen, CEA) NIR-fluorescence probe to ICG in patients scheduled for a resection with high risk of R1, ultimately to reduce the R1 ratio. This is the first trial testing the feasibility of working simultaneously with the two fluorescent dyes. If feasibility is met in this trial, this is a step-up towards a powered trial with primary objective to reduce the rate of R1 resections.
An additional exploratory objective of this study is to investigate the feasibility of SGM-101's potential to isolate circulating tumour cells (CTCs) and tumour-derived extracellular vesicles (EVs) as biomarkers for CRC. The load of CTCs and EVs in the circulation is strongly associated with poor clinical outcomes. Studies have shown that they contain information about the molecular profile of the tumour. The administration of SGM-101 may enable the detection of CEA positive CTCs and EVs.
- Conditions
- Colorectal Cancer, Liver Metastasis Colon Cancer, Image
- Being tested
- SGM-101 op top of ICG
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGM-101 op top of ICGDrug
SGM-101 op top of ICG
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal liver metastases receiving SGM-101 and ICG | Experimental | In total 10 patients will be included who are scheduled for resection of colorectal liver metastases and receive SGM-101 and ICG Receives: Drug: SGM-101 op top of ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases.
It is deemed feasible when it meets all of the following criteria:
- A positive score on practical workability measured with survey A 'practical workability during surgery'
- A positive score on the patient's experience measured with survey B 'patient experience'.
- SGM-101: at least 80% sensitivity, measured as follows:
- For capsular lesions, that are visible in white light are counted positive if TBR ≥ 1.5 in vivo.
- For subcapsular lesions that are not visible in white light will be counted as positive if: A: TBR ≥ 1.5 in vivo, OR B: TBR ≥ 1.5 ex vivo on whole specimen or on bread loafs
- No cross-interference of fluorescent signal of both dyes within the two different excitation and emission channels.
Feasibility is reached when a positive result on all four items is scored.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Dec 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In total 10 patients will be included who are scheduled for resection of colorectal liver metastases and meet at least one of the following criteria: 1. Scheduled for resection of \>3 CRLM or, 2. Completed neo-adjuvant chemotherapy, of which the last course was completed within 3 months before surgery or, 3. Scheduled for surgery because of a locally recurrent liver metastasis.
- 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, Alexander Vahrmeijer, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965817
- Sponsor's protocol ID
- P23
- Acronym
- FOCUS GREEN
- Status last verified
- May 2024
- First submitted
- 20 Jul 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be coded and available only to the researchers of the LUMC on this particular trial. No other people will get access to the data. Results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN
- ClinicalTrials.gov ID
- NCT05965817
- Acronym / sponsor ID
- FOCUS GREEN / P23
- Conditions
- Colorectal Cancer, Liver Metastasis Colon Cancer, Image
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 28 Jul 2023 (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 will be the first trial testing the feasibility of working simultaneously with the two fluorescent dyes ICG and SGM-101 in 10 patients with colorectal metastases.
Detailed description
25-30% of patients with colorectal cancer develop colorectal liver metastases (CRLM). Cornerstone for optimal survival is achieving radical surgical resections of all metastases . To assist the surgeon in achieving this, the use of intra-operative ICG for fluorescent tumour delineation has widely been adopted as standard of care. Multiple international trials have demonstrated that the use of ICG increases the rate of radical resections and result in the detection of additional malignant lesions invisible to the naked eye. However, the rate of false positives is still high and although it has increased the number of radical resections, even in a minimal invasive cohort the unintended R1 rate is still as much as 8%. Therefore, there is a need of an additional real-time intra-operative tool to detect R1 resections, especially in patients with a priori high risk for R1. To illustrate, in a large shared database of the Erasmus University Medical Center was found that patients that either received neoadjuvant chemotherapy, underwent a resection for >3 CRLM or patients that had a locally recurrent liver metastasis were independently associated with high R1 rates, ranging between 23-29%. Therefore, here is proposed the addition of SGM-101, a tumour targeted (carcinoembryonic antigen, CEA) NIR-fluorescence probe to ICG in patients scheduled for a resection with high risk of R1, ultimately to reduce the R1 ratio. This is the first trial testing the feasibility of working simultaneously with the two fluorescent dyes. If feasibility is met in this trial, this is a step-up towards a powered trial with primary objective to reduce the rate of R1 resections.
An additional exploratory objective of this study is to investigate the feasibility of SGM-101's potential to isolate circulating tumour cells (CTCs) and tumour-derived extracellular vesicles (EVs) as biomarkers for CRC. The load of CTCs and EVs in the circulation is strongly associated with poor clinical outcomes. Studies have shown that they contain information about the molecular profile of the tumour. The administration of SGM-101 may enable the detection of CEA positive CTCs and EVs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In total 10 patients will be included who are scheduled for resection of colorectal liver metastases and meet at least one of the following criteria: 1. Scheduled for resection of >3 CRLM or, 2. Completed neo-adjuvant chemotherapy, of which the last course was completed within 3 months before surgery or, 3. Scheduled for surgery because of a locally recurrent liver metastasis.
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal liver metastases receiving SGM-101 and ICG | Experimental | Drug: SGM-101 op top of ICGIn total 10 patients will be included who are scheduled for resection of colorectal liver metastases and receive SGM-101 and ICG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Key exclusion criteria (11 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this 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 |
|---|---|---|
| SGM-101 op top of ICGSGM-101 op top of ICG | Drug | Patients with colorectal liver metastases receiving SGM-101 and ICG |
Primary outcome
To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases.
Time frame: 1.5 years
It is deemed feasible when it meets all of the following criteria: 1. A positive score on practical workability measured with survey A 'practical workability during surgery' 2. A positive score on the patient's experience measured with survey B 'patient experience'. 3. SGM-101: at least 80% sensitivity, measured as follows: * For capsular lesions, that are visible in white light are counted positive if TBR ≥ 1.5 in vivo. * For subcapsular lesions that are not visible in white light will be counted as positive if: A: TBR ≥ 1.5 in vivo, OR B: TBR ≥ 1.5 ex vivo on whole specimen or on bread loafs 4. No cross-interference of fluorescent signal of both dyes within the two different excitation and emission channels. Feasibility is reached when a positive result on all four items is scored.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Data will be coded and available only to the researchers of the LUMC on this particular trial. No other people will get access to the data. Results will be published.
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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 Phase 2 study testing SGM-101 op top of ICG in people with Colorectal Cancer and Liver Metastasis Colon Cancer, run by Leiden University Medical Center 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 7 inclusion and 11 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 9 May 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 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 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.
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 Mats Warmerdam, Msc (0715298420, m.i.warmerdam@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases. (time frame: 1.5 years). 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 9 May 2024.