A phase I/II Study to Evaluate the Safety and Feasibility of Dual-modality imaging using Indium-111-DOTA-labetuzumab-IRDye800CW in patients with Peritoneal Carcinomatosis of Colorectal Origin

A phase I/II Study to Evaluate the Safety and Feasibility of Dual-modality imaging using Indium-111-DOTA-labetuzumab-IRDye800CW in patients with Peritoneal Carcinomatosis of Colorectal Origin - The DuMoPEC study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45898

Enrollment

Registered

2017-06-13

Start date

2018-10-22

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Colo-rectal Peritonitis Carcinomatosa

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clinical diagnosis of peritoneal carcinomatosis of colorectal origin. Scheduled for cytoreductive surgery and HIPEC. Age over 18 years Signed informed consent

Exclusion criteria

Exclusion criteria: Any medical condition present that in the opinion of the investigator will affect patients* clinical status. Administration of a radionuclide within 10 physical half- lives prior to study enrollment Pregnancy or lactation Very high (>500 ng/ml) serum CEA levels Immunohistochemically proven non-CEA expressing primary tumor (if analyzed in primary tumor resection specimen)

Design outcomes

Primary

Measure	Time frame
To assess the feasibility, accuracy and safety of preoperative SPECT/CT and intraoperative fluorescence imaging after administration of 111In-labetuzumab-IRDye800CW in patients with PC of colorectal origin who will undergo cytoreductive surgery and HIPEC.	—

Secondary

Measure	Time frame
To assess whether additional malignant lesions can be visualised by fluorescence imaging after cytoreductive surgery, to assess the correlation between localization of the dual-labeled antibody and CEA expression in tumor and healthy tissue, and to determine the gross blood clearance of 111In-labetuzumab-IRDye800CW in patients.	—

Countries

Netherlands

Outcome results