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Using Diffuse Reflectance Spectroscopy Probes to conduct Optical Measurements during Surgery for Colorectal Cancer

Using Diffuse Reflectance Spectroscopy Probes to conduct Optical Measurements during Surgery for Colorectal Cancer - DRS for In Vivo Margin Assessment in CRC

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57332
Enrollment
74
Registered
2025-02-28
Start date
2025-06-06
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

cancer of the bowel cancer of the rectum colon cancer Colorectal Cancer rectal cancer

Interventions

None listed

Sponsors

Nederlands Kanker Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult (eighteen years or older) written informed consent proven colorectal carcinoma undergoing open surgical resection of tumour (including advanced colorectal primary tumour, colorectal pelvic recurrence (LRRC)) and peritoneal disease (HIPEC)

Exclusion criteria

Exclusion criteria: Suspected oversensitivity to light; e.g. patient who has had photodynamic therapy Use of intravenous fluorescent agents in the area to be measured

Design outcomes

Primary

MeasureTime frame
The first outcome of the study will be the usability of the two probes, assessed using an adapted SUS-score form.

Secondary

MeasureTime frame
The second outcome will be the predictive value of the selected DRS probe used in conjunction with our algorithm to determine a positive resection margin (defined as tumor within 1 mm of the resection edge).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)