Patients undergoing curative surgery for colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10010030 Term: Colorectal cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10
Conditions
Interventions
Product Name: fluorochrome-labeled anti-carcino-embryonic antigen
Product Code: SGM-101
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: SGM-101
Current Sponsor code: SGM-101
Other desc
Sponsors
Surgimab
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged over 18 years old; 2. Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer; 3. Female patients should not be of child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal) nor breastfeeding. Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection; A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 4. Patients should be capable and willing to give informed consent before study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma; 2. Primary appendiceal cancer; 3. Laboratory abnormalities defined as: - Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or; - Total bilirubin above 2 times the ULN or; - Serum creatinine above 1.5 times the ULN or; - Platelet count below 100 x 109/L or; - Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); 4. 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; 5. Use of any investigational drug during 4 weeks before the Injection Day. 6. Any condition that the investigator considers it would potentially jeopardize the patient’s well-being or the study objectives such as severe anaphylactic reaction in medical history, previous allergic reaction to SGM-101 or to any excipient present in the product or known Hypersensitivity to murine proteins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze the clinical benefit resulting from the use of Fluorescence Guided Surgery (FGS) during the surgical procedure, with SGM-101 as the intraoperative imaging agent, in terms of additional cancer lesions resected. ;Secondary Objective: 1. To analyze the clinical benefit resulting from the use of Fluorescence Guided Surgery (FGS) during the surgical procedure, with SGM-101 as the intraoperative imaging agent, in terms of preservation of non-cancer tissue. 2. To analyze the false detection rate of FGS during the surgical procedure, with SGM-101 as the intraoperative imaging agent. 3. To analyze the clinical benefit resulting from the use of FGS during the surgical procedure, with SGM-101 as the intraoperative imaging agent, in terms of overall benefit. 4. Diagnostic performance of FGS: Accuracy 5. To further characterize diagnostic performance by analyzing the PPV, NPV, Sensitivity and Specificity of FGS. 6. Diagnostic performance of FGS versus fresh frozen sections. 7. To describe the TBR 8. To document the impact of SGM-101 injection on the surgical procedure 9. To evaluate tolerability/safety of SGM-101 injection 10. To evaluate short term surgical outcomes;Primary end point(s): Proportion of patients who have at least one additional biopsy/ resection identified under NIR but not under WL that are true positives (TP).;Timepoint(s) of evaluation of this end point: Day of the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.“Conservative surgery benefit” rate: P2 Proportion of patients who have more [WL positive, NIR negative, pathology negative lesions] (NIR true negatives) than [WL negative, NIR positive, pathology negative] (NIR false positive) lesions, i.e. a net benefit in numbers of negative lesions wrongly resected. 2. False detection rate: P3 Proportion of patients who have all additional biopsies / resections under NIR that are false positives (FP). 3. Composite endpoint at the patient level: Clinical benefit (or “positive” change in surgery plan or post-surgical management of the patient resulting from the use of FGS) rate P4. Clinical benefit will be assessed within each patient by comparing standard of care surgery without fluorescence to surgery with fluorescence and assessing if the latter allowed to remove any additional pathologically confirmed malignant lesion and/or to resect less nonmalignant tissue, and/or to adapt the post-surgical management, each patient serving as his own control. The outcome measure will be the rate of patients with clinical benefit. 4. The accuracy rate will be used as the main endpoint to assess intraoperative imaging agent performance. The statistical analysis will consist in describing the concordance between FGS using SGM-101 as intraoperative imaging agent and the pathology results (final pathology when available or FFS if not sent to pathology) with respect to the presence of cancer using rates of true positives (TP), false positives (FP), false negatives (FN), true negatives (TN) and the accuracy rate (TP+TN). These will be computed at the patient level for both all lesions and additional lesions identified with fluorescent light only, and at lesion level. 5. •Positive Predictive value (PPV) (percentage of histologically (final pathology when available or FFS if not sent to pathology) positive lesions among fluorescent lesions), •Negative Predictive value (NPV) (percentage of histologically (final patholog | — |
Countries
Germany, Italy, Netherlands, United States
Contacts
Public ContactFrançoise Cailler
Surgimab
Outcome results
None listed