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Intraoperative near-infrared fluorescence imaging of colorectal carcinoma with cRGD-ZW800-1 and dedicated imaging systems: A Phase II study

Fluorescence imaging with cRGD-ZW800-1

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22876
Enrollment
12
Registered
2019-05-10
Start date
2018-09-18
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal carcinoma

Interventions

Sponsors

Leiden University Medical Center, Leiden, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems

Secondary

MeasureTime frame
To define the optimal dose of cRGD-ZW800-1 for intraoperative near-infrared fluorescence imaging of tumors.

Contacts

Public ContactAlexander Vahrmeijer

LUMC

a.l.vahrmeijer@lumc.nl071-5266159

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)