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Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.

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ClinicalTrials.gov Identifier: NCT01982227
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : January 30, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm.

Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries.

The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated.

This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.


Condition or disease Intervention/treatment
Colorectal Cancer Metastatic Drug: indocyanine green

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Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Prospective
Official Title: Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.
Study Start Date : March 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients
Patients (Aged 18 to 70 inclusive) with progressive colorectal cancer in intra-abdominal surgery requiring resection +/- Chemotherapy Hyperthermic Intraperitoneal
Drug: indocyanine green
intravenous injection (0.25mg/kg) of the indocyanine green 24h before the surgery.




Primary Outcome Measures :
  1. Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo [ Time Frame: At the end of the surgery ]
    Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo


Secondary Outcome Measures :
  1. Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo peritoneal cancer index (PCI) score with and without fluorescence [ Time Frame: At the end of the surgery ]
    Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence

  2. Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence [ Time Frame: At de begining of the surgery ]
    Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection +/- Chemotherapy Hyperthermic Intraperitoneal
Criteria

Inclusion Criteria:

  • Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection + / - Chemotherapy Hyperthermic Intraperitoneal
  • Aged 18 to 70 inclusive
  • Signature information form and consent by the patient

Exclusion Criteria:

  • Pregnant women, a urine pregnancy test or blood will be realized within 72 hours before surgery
  • Contraindication to surgery
  • Diagnosis not confirmed colorectal adenocarcinoma
  • Persons major subject of legal protection or unable to consent

Information from the National Library of Medicine

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): NCT01982227


Locations
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France
CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Gabrielle BARABINO, MD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01982227     History of Changes
Other Study ID Numbers: 1208138
2012-004314-34 ( EudraCT Number )
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
colorectal cancer metastatic
indocyanine green

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases