Chimeric monoclonal antibody against carcinoembryonic antigen conjugated to fluorochrome BM-104 for Early rectal cancer | High-grade dysplasia

Inclusion criteria

• {"criterion_text":"- 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.\n- Age > 18 years old\n- Patients should be capable and willing to give signed informed consent before study specific procedures."}

Exclusion criteria

• {"criterion_text":"- Prior participation in this study\n- Previous administration of SGM-101\n- Patients with a history of anaphylactic shock\n- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential\n- Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives"}

Primary endpoints

• {"endpoint_text":"- The ex-vivo NIR-fluorescence TDR (T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic).","definition_or_measurement_approach":"TDR (T1RC/HGD to LGD ratio) measured ex-vivo using NIR-fluorescence on bread loaf (macroscopic) specimens and on pathology slides (microscopic)."}

Secondary endpoints

• {"endpoint_text":"- 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)\n- In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope.\n- 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\n- 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)\n- The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)\n- 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\n- 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","definition_or_measurement_approach":"Ex-vivo TBR/DBR: measured on whole specimens, bread loafs and slides using Quest open camera, PEARL and a dedicated 700nm microscopy scanner. In-vivo TDR/TBR/DBR: measured with the Quest spectrum laparoscope. Accuracy (ex-vivo/in-vivo): classification using TDR threshold (≥1.5 = true positive; <1.5 = false negative) with calculation of percentage true positives/false positives/false negatives/true negatives; same approach applied for TBR and DBR. Correlation endpoints: statistical correlation between in-vivo fluorescence ratios (TBR/TDR) and Kudo invasion level (SM1 vs SM2/3). Resection margin agreement: classification of margin positivity by presence of fluorescent hotspot correlated to histopathology. CEA expression ratio: IHC quantified by immunoreactive score (IRS); IRS(T1RC/HGD)/IRS(LGD) correlated to measured TDR."}

Netherlands

Earliest CTIS Part Ii Submission Date

08-10-2024

Latest Decision Or Authorization Date

16-10-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Academisch Ziekenhuis Leiden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands