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Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer: A Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003186
Enrollment
Unknown
Registered
2004-05-19
Start date
1997-04-30
Completion date
Unknown
Last updated
2013-02-05

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

Conditions

Colorectal Cancer, Metastatic Cancer

Keywords

stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, adenocarcinoma of the colon, liver metastases

Brief summary

RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of patients with metastatic colorectal cancer. PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients.

Detailed description

OBJECTIVES: I. Confirm that injection of isosulfan blue into the mucosa or serosa immediately adjacent to a colorectal cancer results in the lymphatic transport of that agent initially to a specific regional lymph node that can readily be identified on visual inspection, dissected, and histologically evaluated for the presence or absence of metastatic disease. OUTLINE: All patients receive an injection of isosulfan blue into peritumor serosa upon intraoperative identification of the primary tumor, prior to mesenteric mobilization. If colonoscopy is otherwise indicated, the injection may be delivered to the peritumor mucosa via colonoscopy during the case. The mesentery adjacent to the injection is inspected and the lymphatic pattern and nodes demonstrated by the isosulfan blue are diagrammed and photographed. The sentinel node(s) are surgically dissected and evaluated. If needed, a second injection of isosulfan blue may be given. Prior to mobilization of liver for resection of metastases, isosulfan blue is injected subcapsularly around the metastatic lesion. PROJECTED ACCRUAL: There will be 10 patients accrued into this study.

Interventions

PROCEDUREsentinel lymph node biopsy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: Patients must be undergoing surgical resection of a colorectal primary adenocarcinoma Metastatic colorectal cancer to liver (hepatic metastases) allowed PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known or suspected allergy to isosulfan blue Not pregnant PRIOR CONCURRENT THERAPY: See Disease Characteristics

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026