SGM-101 will make colorectal lung metastasis better visible using a near infrared camera
ID
Bron
Verkorte titel
Aandoening
colorectal lung metastases
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Concordance between intraoperative fluorescence assessment of resected lesions and their histopathologic result
Achtergrond van het onderzoek
This is a national phase II, multicenter, exploratory, open label clinical trial on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for the intraoperative detection of colorectal lung metastases. Patients will be followed for a total duration of 1 month postoperatively.
Doel van het onderzoek
SGM-101 will make colorectal lung metastasis better visible using a near infrared camera
Onderzoeksopzet
30 days post treatment
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Signed informed consent prior to any study-mandated procedure;
2. Patients aged over 18 years old;
3. 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.
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
5. Diagnosed with lung metastasis of colorectal origin and scheduled for a resection.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. History of any anaphylactic reaction;
2. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
3. Laboratory abnormalities defined as:
a. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
b. Total bilirubin above 2 times the ULN or;
c. Serum creatinine above 1.5 times the ULN or;
d. Platelet count below 100 x 109/L or;
e. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
f. 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;
4. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
5. Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7751 |
CCMO | NL70103.058.19 |
OMON | NL-OMON52798 |