Real-time visualization of colorectal carcinoma during surgery with fluorescence
ID
Bron
Verkorte titel
Aandoening
Colorectal carcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems
Achtergrond van het onderzoek
Surgery remains the primary treatment for colorectal cancer where complete removal of all malignant tissue is the cornerstone of curative intended oncologic surgery. However, discriminating between malignant and benign tissue can be challenging, especially after neoadjuvant treatment. Near-infrared fluorescence imaging with cRGD-ZW800-1 can provide accurate and real-time visualization of tumors during surgery.
Doel van het onderzoek
Real-time visualization of colorectal carcinoma during surgery with fluorescence
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
cRGD-ZW800-1 injection prior to surgery
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) Patients > 18 years old;
2) Patients scheduled and eligible for resection because of colorectal carcinoma;
3) Patients should be capable and willing to give informed consent before study specific procedures;
4) Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant;
5) The patient has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening;
6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients will be excluded if any of the criteria below apply:
1) History of a clinically significant allergy or anaphylactic reactions;
2) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
3) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7724 |
Ander register | METC LUMC : P17.242 |