Colorectal Neoplasms
Conditions
Keywords
Fluorescence, Cancer, SGM-101, Surgery, Colorectal
Brief summary
The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard white light visualization during surgical resections of colorectal cancer.
Detailed description
The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard white light visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.
Interventions
DRUGSGM-101
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
Sponsors
Surgimab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two parallel arms consisting of a treatment arm of patients who will receive the study drug and subsequently undergo surgical resections under both standard white light conditions and then NIR, and a no treatment arm to whom the study drug will not be administered and who will undergo surgical resections under standard white light conditions only.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). 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.
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; * Absolute neutrophils counts below 1.5 x 109/L 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. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical resection histopathology. | Through completion of surgery, up to 9 weeks. | Comparison of surgical resections using histopathology as standard of truth.. |
Countries
Germany, Italy, Netherlands, United States
Contacts
Primary ContactJohn Warner, JD, MPA
Backup ContactFrançoise Cailler, PhD
Outcome results
None listed