NCT00185081

Brief Summary

The purpose of this study is to test the safety of the peptide and antibody and at the same time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

3.4 years

First QC Date

September 15, 2005

Last Update Submit

April 6, 2016

Conditions

Colonic Neoplasms

Keywords

colon cancerradioimmunoscintigraphycolon-specific antigen,radioimmunotherapy,radioimmunodetection

Outcome Measures

Primary Outcomes (3)

  • Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734

  • Tumor targeting of In-IMP-205 in patients with colorectal carcinoma

  • Pharmacokinetics, biodistribution and dosimetry of In-IMP-205

Interventions

Indium labeled IMP-205xm734DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years of age
  • Histologic or cytologic diagnosis of colorectal cancer
  • Karnofsky performance status \>70%

You may not qualify if:

  • Pregnant or lactating women
  • Severe anorexia
  • Active second primary malignancy
  • Chemotherapy or radiotherapy within four weeks of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Wim Oyen, MD PhD

    Radboud University Medical Centre Nijmegen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

July 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

NL(1)