Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin (MMIPC)
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|ClinicalTrials.gov Identifier: NCT03699332|
Recruitment Status : Unknown
Verified September 2019 by Radboud University Medical Center.
Recruitment status was: Recruiting
First Posted : October 9, 2018
Last Update Posted : September 13, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Carcinomatosis Colorectal Cancer Carcinoma Neoplasms Gastrointestinal Cancer||Drug: Indium-111-DOTA-Labetuzumab-IRDye800CW injection Radiation: SPECT/CT scan Procedure: CRS extended with dual-modality imaging||Phase 1 Phase 2|
In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. When performing cytoreductive surgery (CRS) for peritoneal carcinomatosis of colorectal origin it can sometimes be difficult to distinguish tumor deposits from adhesions and scar tissue. Intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen. Labetuzumab specifically recognises CEA which is expressed on > 95% of all colorectal cancers. Therefore Indium-111-DOTA-labetuzumab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in peritoneal carcinomatosis of colorectal origin. The concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.
Eligible patients with peritoneal carcinomatosis of colorectal origin scheduled for CRS + HIPEC will receive dual-labeled labetuzumab 6-7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen and thorax will be obtained. Cytoreductive surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe.
The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-labetuzumab-IRDye800CW in peritoneal carcinomatosis of colorectal cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study to Evaluate the Safety and Feasibility of Multi-modality Imaging Using Indium-111-DOTA-labetuzumab-IRDye800CW in Patients With Peritoneal Carcinomatosis of Colorectal Origin|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Intraoperative multi-modality imaging
Patients receive a single intravenous dose of Indium-111-DOTA-Labetuzumab-IRDye800CW. At day 4 or 5 after antibody injection a SPECT/CT scan will be acquired. At day 6 or 7 standard of care cytoreductive surgery will be performed. This will be extended with the use of dual-modality imaging.
Drug: Indium-111-DOTA-Labetuzumab-IRDye800CW injection
Radiation: SPECT/CT scan
Abdominal and thoracic SPECT/CT scan.
Procedure: CRS extended with dual-modality imaging
cytoreductive surgery will be performed extended with the use of dual-modality imaging.
- Fluorescent signal at time of surgery [ Time Frame: During cytoreductive surgery ]Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No
- Safety of dual-labeled antibody (labetuzumab) as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 [ Time Frame: 4 weeks ]Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0
- Blood levels of the dual-labeled antibody [ Time Frame: 60, 120 and 180 minutes after injection and 4 and 7 days after injection ]Blood samples will be measured for radioactivity in a gamma counter at different timepoints after injection. This will be expressed as percentage injected dose per gram (%ID/g)
- Optimal dose of the dual-labeled antibody preparation [ Time Frame: 4 weeks ]Optimal dose of dual-labeled antibody for dual modality image guided surgery
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clinical diagnosis of peritoneal carcinomatosis of colorectal origin
- Scheduled for cytoreductive surgery and HIPEC.
- Age over 18 years
- Signed informed consent
- Any medical condition present that in the opinion of the investigator will affect patients clinicals status
- Administration of a radionuclide within 10 physical half-lives prior to study enrollment
- Pregnancy or lactation
- Patients with very high (>500ng/ml serum CEA levels
- Known CEA negative tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699332
|Contact: FMK Elekonawo, MD||0031 24 3619097||Fortune.Elekonawo@radboudumc.nl|
|Contact: JM de Gooyer, MD||0031 24 3667244||Jan-Marie.Gooyer@radboudumc.nl|
|Nijmegen, Netherlands, 6525 GA|
|Contact: Jan-Marie de Gooyer, MD|
|Principal Investigator:||JHW de Wilt, MD, PhD||Radboud University Medical Center|
|Responsible Party:||Radboud University Medical Center|
|Other Study ID Numbers:||
|First Posted:||October 9, 2018 Key Record Dates|
|Last Update Posted:||September 13, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
image guided surgery
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological