Radio-controlled Surgery RGS in the cancer of the rectum clinical study of feasibility to improve the treatment and prognosis - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001499-18-IT

Enrollment

Registered

2006-11-24

Start date

2006-05-12

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

carcinoma of the rectum MedDRA version: 8.1 Level: PT Classification code 10038038 Term: Rectal cancer

Interventions

Product Name: Nanocoll Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Technetium 99mTc human albumin Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologic diagnosis of carcinoma of rectum PS 70 according to Karnovsky Age 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient not electable; Women in pregnancy and breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the effectiveness, the accuracy and sensibility of the technology of the radioisotope in the finding of LS in the cancer of the rectum or its relapses;Secondary Objective: Comparison between appraisal RGS and the preoperative instrumental stage; Comparison between appraisal RGS and the histopathological characterization;;Primary end point(s): Validation of methodology in the cancer of the rectum.	—

Measure

Time frame

Main Objective: To demonstrate the effectiveness, the accuracy and sensibility of the technology of the radioisotope in the finding of LS in the cancer of the rectum or its relapses;Secondary Objective: Comparison between appraisal RGS and the preoperative instrumental stage; Comparison between appraisal RGS and the histopathological characterization;;Primary end point(s): Validation of methodology in the cancer of the rectum.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026