SGM-T1: SGM-101 tumor targeted fluorescence endoscopy in rectal polyps with suspected T1 adenocarcinoma or high grade dysplasia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Leiden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

7 Dec 2023 → ongoing

Decision date (initial)

2024-10-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-510769-41-00

EudraCT number

2023-000171-13

ClinicalTrials.gov

NCT06280690

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis, Prophylaxis

The main objective is to investigate the feasibility of a tumour-targeted fluorescent tracer SGM-101, combined with the use of theCE-marked fluorescence-laparoscope of Quest Medical Imaging, to discriminate between normal, LGD and malignant tissue (HGD,T1RC) in patients with suspected T1/HGD rectal cancer.
It consists of two phases for which primary objectives are defined separately:
Phase I: Dose optimization phase to determine the optimal dose of SGM-101
Phase II: feasibility assessment of tumor-targeted fluorescence endoscopy with the use of SGM-101 in discriminating normal, LGDand malignant tissue (HGD, T1RC).

Conditions and MedDRA coding

Early rectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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.
2. Age > 18 years old
3. Patients should be capable and willing to give signed informed consent before study specific procedures.

Exclusion criteria 5

1. Prior participation in this study
2. Previous administration of SGM-101
3. Patients with a history of anaphylactic shock
4. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
5. Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The ex-vivo NIR-fluorescence TDR (T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic).

Secondary endpoints 7

1. Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective) on whole specimen (Quest open camera, PEARL), bread loafs (Quest open camera and PEARL) and slides (dedicated 700nm microscopy scanner)
2. In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope.
3. The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo on whole specimen (Quest open camera, PEARL), bread loafs (Quest open camera and PEARL) and slides (dedicated 700nm microscopy scanner). A TDR of ≥1,5 is defined as true positive. A TDR of <1.5 is defined as false negative. The accuracy is defined as the percentage of patients that are true positive. Same analysis will be performed for TBR and DBR
4. The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo with the Quest laparoscope. Accompanying endpoint is the percentage of true positives (fluorescent spot in- vivo correlated to T1RC/HGD at pathology), false negatives (no fluorescent hotspot in vivo, T1RC/HGD component at pathology), false positives (fluorescent hotspot in-vivo, no T1RC/HGD at pathology) and true negatives (no fluorescent hotspot in vivo, no T1RC/HGD at pathology)
5. The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)
6. 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
7. The ratio of tissue CEA expression of T1RC/HGD divided by LGD, to TDR. The amount of CEA expression is determined by immunohistochemistry and quantified using the immunoreactive score (IRS)[28]. The ratio is calculated by dividing the IRS of T1RC/HGD by the IRS of LGD, after which this ratio is correlated to the TDR

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Leiden

Sponsor organisation

Academisch Ziekenhuis Leiden

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center

Public contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications