Colorectal CancerPhase 2SGM-T1NCT06280690
SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia
A Phase 2 study testing SGM-101 in people with Colorectal Cancer and Image, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Image, Low Grade Dysplasia of Colon
- What is being tested?
- SGM-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Jan 2024to 30 Jul 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
- Patient must have suspected T1RC/HGD and scheduled for a local endoscopic en-bloc resection. The rectum is defined as the area between the linea dentata and 10cm ab ano.
- Age > 18 years old
- Patients should be capable and willing to give signed informed consent before study specific procedures.
Who cannot join
- Prior participation in this study
- Previous administration of SGM-101
- Patients with a history of anaphylactic shock
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
- Any condition that the investigator considers to be potentially jeopardizing the patients' 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
Official title: SGM-101 Tumor-targeted Fluorescence Endoscopy to Enable Discrimination of Malignant From Benign Tissue in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia: a Feasibility Study
This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101.
Read the detailed description
Selection of patients with early rectal cancer, T1 rectal cancer (T1RC) or high-grade dysplasia (HGD), for local resection is based on endoscopic imaging, endorectal ultrasound and/or MRI. However, all these imaging modalities have their limitations in the accurate detection of small areas of cancer in large rectal polyps. Fluorescent guided endoscopy may offer the opportunity to aid in detecting these small cancerous areas in colorectal polyps.
Detection of T1RC or HGD in large rectal polyps is essential to select patients for the appropriate (endoscopic) resection technique. Completely benign polyps, solely containing low-grade dysplasia (LGD), could be resected by piecemeal endoscopic mucosal resection (pEMR), a fast technique on which almost all endoscopists are trained. However, for rectal polyps with T1RC or HGD, curative resection must be achieved by en-bloc resection techniques such as endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID). These techniques are more complex and expensive and only a small number of endoscopists are trained on these techniques. pEMR of lesions with HGD or T1RC must be avoided because they may result in irradical resections (R1) or in inconclusive histological margin assessment since the polyp is not resected en-bloc. Often, this leads to unnecessary additional abdominal surgical resections.
Furthermore reported sensitivities for optical diagnosis of T1RC in a polyp are low, varying from 20.8% to 77.8%. Because of the limited accuracy of optical diagnosis, the current Dutch guideline suggest that rectal polyps >3cm should be resected in an en-bloc manner, although it has been demonstrated that only 10.2% of rectal polyps >3cm contain a malignant component. Similarly, in recent studies it was shown that 10-15% of entirely benign polyps were removed by abdominal surgery rather than endoscopically. This has major implications for the patient since surgical resection is associated with considerable morbidity. Therefore, there is a need of a technique that provide the endoscopist with real-time information about specific molecular features of the tumor to differentiate between benign polyps with LGD amenable for pEMR and those that contain HGD or T1RC that require en-bloc resection. Tumor targeted fluorescence-guided surgery (FGS) has emerged as a technique with the potential to enable real-time lesion visualization based on specific molecular features rather than on morphology. Recently it was shown that carcinoembryonic antigen (CEA) is overexpressed in approximately 75% of T1RC/HGD. Additionally, expression in LGD was (nearly) absent in 66% of low-grade dysplastic tissue and in 98% of normal rectum tissue, making it a suitable marker for distinguishing T1RC and HGD from LGD and normal tissue. CEA can be targeted by SGM-101, an anti-CEA antibody attached to a fluorophore which has been studied in several clinical studies for patients with colorectal cancer undergoing surgery. The investigators hypothesize that the use of SGM-101 during endoscopy aids the endoscopist in discriminating benign polyps with solely LGD from polyps containing T1RC/HGD.
- Conditions
- Colorectal Cancer, Image, Low Grade Dysplasia of Colon
- Being tested
- SGM-101
- 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-101Drug
SGM-101 is cea-targeted fluorescent dye
| Study group | Role | What they receive |
|---|---|---|
| 10mg SGM-101 | Experimental | This cohort receives 10mg Receives: Drug: SGM-101 |
| 5mg SGM-101 | Experimental | This cohort receives 5mg Receives: Drug: SGM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic).
The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic).
Measured: 1.5 years
Secondary outcomes (6)
- Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective)
Measured: 1.5 years
- In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope.
Measured: 1.5 years
- The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo
Measured: 1.5 years
-The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo
Measured: 1.5 years
- The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)
Measured: 1.5 years
- The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen.
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 Feb 2024
- Study start31 Jan 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC).
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06280690
- Sponsor's protocol ID
- NL83765.058.23
- Acronym
- SGM-T1
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 29 Feb 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.
Publications
Warmerdam MI, Dijkhuis TH, Linders DJG, Pesch CMW, Crobach ASLP, Matoshi A, Basiliya K, van den Berg SH, Cailler F, Peeters KCMJ, Holman FA, Mieog JSD, Vahrmeijer AL, Hilling DE, Boonstra JJ. CEA-targeted fluorescence endoscopy for the detection of high-grade dysplasia and early invasive rectal cancer: A proof-of-concept trial. Eur J Nucl Med Mol Imaging. 2026 Sep 3. doi: 10.1007/s00259-026-08155-z. Online ahead of print.
PubMed 42690333
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGM-101 Tumor-targeted Fluorescence Endoscopy to Enable Discrimination of Malignant From Benign Tissue in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06280690
- Acronym / sponsor ID
- SGM-T1 / NL83765.058.23
- Conditions
- Colorectal Cancer, Image, Low Grade Dysplasia of Colon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 28 Feb 2024 (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 investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101.
Detailed description
Selection of patients with early rectal cancer, T1 rectal cancer (T1RC) or high-grade dysplasia (HGD), for local resection is based on endoscopic imaging, endorectal ultrasound and/or MRI. However, all these imaging modalities have their limitations in the accurate detection of small areas of cancer in large rectal polyps. Fluorescent guided endoscopy may offer the opportunity to aid in detecting these small cancerous areas in colorectal polyps.
Detection of T1RC or HGD in large rectal polyps is essential to select patients for the appropriate (endoscopic) resection technique. Completely benign polyps, solely containing low-grade dysplasia (LGD), could be resected by piecemeal endoscopic mucosal resection (pEMR), a fast technique on which almost all endoscopists are trained. However, for rectal polyps with T1RC or HGD, curative resection must be achieved by en-bloc resection techniques such as endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID). These techniques are more complex and expensive and only a small number of endoscopists are trained on these techniques. pEMR of lesions with HGD or T1RC must be avoided because they may result in irradical resections (R1) or in inconclusive histological margin assessment since the polyp is not resected en-bloc. Often, this leads to unnecessary additional abdominal surgical resections.
Furthermore reported sensitivities for optical diagnosis of T1RC in a polyp are low, varying from 20.8% to 77.8%. Because of the limited accuracy of optical diagnosis, the current Dutch guideline suggest that rectal polyps >3cm should be resected in an en-bloc manner, although it has been demonstrated that only 10.2% of rectal polyps >3cm contain a malignant component. Similarly, in recent studies it was shown that 10-15% of entirely benign polyps were removed by abdominal surgery rather than endoscopically. This has major implications for the patient since surgical resection is associated with considerable morbidity. Therefore, there is a need of a technique that provide the endoscopist with real-time information about specific molecular features of the tumor to differentiate between benign polyps with LGD amenable for pEMR and those that contain HGD or T1RC that require en-bloc resection. Tumor targeted fluorescence-guided surgery (FGS) has emerged as a technique with the potential to enable real-time lesion visualization based on specific molecular features rather than on morphology. Recently it was shown that carcinoembryonic antigen (CEA) is overexpressed in approximately 75% of T1RC/HGD. Additionally, expression in LGD was (nearly) absent in 66% of low-grade dysplastic tissue and in 98% of normal rectum tissue, making it a suitable marker for distinguishing T1RC and HGD from LGD and normal tissue. CEA can be targeted by SGM-101, an anti-CEA antibody attached to a fluorophore which has been studied in several clinical studies for patients with colorectal cancer undergoing surgery. The investigators hypothesize that the use of SGM-101 during endoscopy aids the endoscopist in discriminating benign polyps with solely LGD from polyps containing T1RC/HGD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC).
| Arm | Type | Receives |
|---|---|---|
| 10mg SGM-101 | Experimental | Drug: SGM-101This cohort receives 10mg |
| 5mg SGM-101 | Experimental | Drug: SGM-101This cohort receives 5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must have suspected T1RC/HGD and scheduled for a local endoscopic en-bloc resection. The rectum is defined as the area between the linea dentata and 10cm ab ano.
- Age > 18 years old
- Patients should be capable and willing to give signed informed consent before study specific procedures.
Key exclusion criteria (5 listed)
- Prior participation in this study
- Previous administration of SGM-101
- Patients with a history of anaphylactic shock
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
- Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.
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-101SGM-101 is cea-targeted fluorescent dye | Drug | 10mg SGM-101, 5mg SGM-101 |
Primary outcome
The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic).
Time frame: 1.5 years
The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic).
6 secondary outcomes
- Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective)
Time frame: 1.5 years
- In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope.
Time frame: 1.5 years
- The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo
Time frame: 1.5 years
-The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo
Time frame: 1.5 years
- The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)
Time frame: 1.5 years
- The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen.
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 42690333Warmerdam MI, Dijkhuis TH, Linders DJG, Pesch CMW, Crobach ASLP, Matoshi A, Basiliya K, van den Berg SH, Cailler F, Peeters KCMJ, Holman FA, Mieog JSD, Vahrmeijer AL, Hilling DE, Boonstra JJ. CEA-targeted fluorescence endoscopy for the detection of high-grade dysplasia and early invasive rectal cancer: A proof-of-concept trial. Eur J Nucl Med Mol Imaging. 2026 Sep 3. doi: 10.1007/s00259-026-08155-z. Online ahead of print.
- 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 in people with Colorectal Cancer and Image, 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 3 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: status not confirmed, as of the sponsor's last update on 29 Feb 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 (+31715298420, 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?
The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic). (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?
On the ClinicalTrials.gov record for NCT06280690, which also lists 1 linked publication.
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 29 Feb 2024.