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Completed

NCT Number: NCT00185081

Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Radboud University Medical Centre Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

Colo-rectal cancer has an incidence of 8000 cases per year in The Netherlands. Eventually 50% of them will die as a consequence of this disease.

Treatment consists of resection of the primary tumor, followed by adjuvant chemotherapy in some patients. The chemotherapeutical agents, however, are only moderately effective with regard to increase of survival. New treatment modalities are therefore desirable.

Radioimmunotherapy using radioactive labelled antibodies have proven to be effective in hematologic malignancies. Due to slow absorption in solid tumors however an effective radiation dose is not yet achieved.

The aim of our study is to bypass this slow tumor uptake by the use of pre-targeting. We therefore use an unlabeled bispecific antibody infusion. This will be followed several days later by the infusion of a radiolabeled peptide that binds to the bispecific antibody.

We hypothesise that this small peptide will be readily absorbed by the tumor which is pre-saturated by the bispecific antibody. As a consequence a higher radiation dose can be given with a lower toxicity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Indium labeled IMP-205xm734

Drug

Primary outcomes

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

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

  3. Pharmacokinetics, biodistribution and dosimetry of In-IMP-205

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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