Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04642924
Other study ID # L19-069
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 22, 2019
Est. completion date October 2023

Study information

Verified date November 2020
Source Leiden University Medical Center
Contact Ruben Meijer
Phone +31 71-52 98420
Email r.p.j.meijer@lumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Near-infrared fluorescence-guided oncologic surgery (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. Subsequently, this may drastically improve patient care by improving oncologic outcome.


Recruitment information / eligibility

Status Recruiting
Enrollment 203
Est. completion date October 2023
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients aged over 18 years old; 2. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment. 3. Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000) 4. Patients should be capable and willing to give signed informed consent before study specific procedures. Exclusion Criteria: 1. Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma. 2. Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery) 3. Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery) 4. Patient with a history of a clinically significant allergy. 5. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential; 6. Laboratory abnormalities defined as: 1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or; 2. Total bilirubin above 2 times the ULN or; 3. Serum creatinine above 1.5 times the ULN or; 4. Platelet count below 100 x 109/L or; 5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); 6. 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; 7. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives. 8. Previous administration of SGM-101

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SGM-101
Fluorescence-guided surgery

Locations

Country Name City State
Netherlands Amsterdam University Medical Center Amsterdam
Netherlands Haaglanden Medisch Centrum Den Haag
Netherlands Catharina Hospital Eindhoven Eindhoven
Netherlands Erasmus Medical Center Rotterdam

Sponsors (8)

Lead Sponsor Collaborator
Leiden University Medical Center Catharina Ziekenhuis Eindhoven, Centre for Human Drug Research, Netherlands, Erasmus Medical Center, Medical Center Haaglanden, Quest Medical Imaging, Surgimab, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resection status Pathologic resection status (R0 or R1) 10 days post surgery
See also
  Status Clinical Trial Phase
Recruiting NCT06380101 - Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) N/A
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Recruiting NCT04323722 - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Active, not recruiting NCT01347697 - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer N/A
Recruiting NCT04495088 - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer Phase 3
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Not yet recruiting NCT03520088 - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS N/A
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Recruiting NCT04749381 - The Role of TCM on ERAS of Rectal Cancer Patients Phase 2
Enrolling by invitation NCT05028192 - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Recruiting NCT03283540 - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Recruiting NCT05914766 - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer N/A
Recruiting NCT04852653 - A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Terminated NCT02933944 - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer Phase 1