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JOURNAL ONKOLOGIE – STUDIE

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

Rekrutierend

NCT-Nummer:
NCT03659448

Studienbeginn:
Juni 2019

Letztes Update:
09.01.2024

Wirkstoff:
SGM-101

Indikation (Clinical Trials):
Colorectal Neoplasms, Recurrence

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Surgimab

Collaborator:
-

Studienleiter

Alex L. Vahrmeijer,, MD, PhD
Principal Investigator
Leiden University Medical Center, Leiden, The Netherlands

Kontakt

Studienlocations
(3 von 10)

Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
37075 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jens Sperling, MD
Phone: +49 551 39 7989
E-Mail: Jens.Sperling@med.uni-goettingen.de

Johanna Kreutzer, Ph.D.
E-Mail: johanna.kreutzer@med.uni-goettingen.de» Ansprechpartner anzeigen
Moores Cancer Center - UCSD Health
92093 La Jolla
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Sonia L Ramamoorthy, MD
Phone: 858-657-6100
E-Mail: sramamoorthy@ucsd.edu

Dad Shakeela, Ph.D.
Phone: (858) 822-5376
E-Mail: sdad@ucsd.edu» Ansprechpartner anzeigen
Cleveland Clinic Florida
33331 Weston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
David J MARON, MD
Phone: 954-659-5278
E-Mail: MAROND@ccf.org

Maria MEJIA, BS, CCRP
Phone: (954) 659-5888
E-Mail: MEJIAGM@ccf.org» Ansprechpartner anzeigen
Massachusetts General Hospital
02114 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Rocco Ricciardi, MD
E-Mail: RRICCIARDI1@mgh.harvard.edu

Caitlin Stafford
Phone: 617-643-7869
E-Mail: CSTAFFORD2@partners.org» Ansprechpartner anzeigen
Leiden University Medical Center
2333 CL Leiden
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Alexander L Vahrmeijer, MD, Ph.D.
Phone: +31 71 5262309
E-Mail: a.l.vahrmeijer@lumc.nl

Ruben P Meijer, MD
Phone: ‭+31 71 7517143
E-Mail: R.P.J.Meijer@lumc.nl» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Surgical resection histopathology. (Time Frame - Through completion of surgery, up to 9 weeks.):
Comparison of surgical resections using histopathology as standard of truth..

Studien-Arme

  • Active Comparator: Treatment
    Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR.
  • No Intervention: No Treatment
    Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.

Geprüfte Regime

  • SGM-101:
    A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.

Quelle: ClinicalTrials.gov


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"Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer"

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