Search / Trial NCT00001568

Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Tumors Detection Follow Up Markers Radiolabeled

Description

Recurrences following resection for colorectal carcinoma occur in 50% of patients. Early detection and management of recurrences results in improved survival. Post-operative surveillance consists of serial CT scans, chest x-rays, colonoscopy and CEA determinations. Elevations in the serum CEA level can be the earliest and most sensitive indicator of recurrence. A rise in the serum CEA level in the absence of imageable disease presents a particular diagnostic challenge. Advanced imaging modalities such as Positron Emission Tomography (PET) and anti-CEA antibody immunoscintigraphy have been p...

Gender

All

Eligibility criteria

  • All patients greater than 18 years old who have had a prior resection of colorectal cancer and are suspected of having recurrent disease.
  • Rising serum CEA levels greater than 6 on two successive tests.
  • Resectable residual or recurrent disease. Patients in the occult arm (Arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. In addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; CT scan of chest/ abdomen/ pelvis with contrast, MRI scan, and chest x-ray. Patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.
  • Patients must have an ECOG performance status of 0-1.
  • Patients must be willing to return to NIH for follow-up.
  • Patients must be able to provide informed consent as demonstrated by the signed consent.
  • Patients must be 2 or more months from abdominal or thoracic surgery.
  • No patients with medical contraindication to abdominal exploration.
  • No patients with recurrent disease detected by conventional imaging studies as outlined above. Metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. Patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.
  • No patients with previous injection of murine monoclonal antibodies: Human anti-mouse assay (HAMA) will be performed in patients with prior history of receiving murine monoclonal antibodies.
  • No patients that are pregnant or breast feeding.
  • Patients who are HIV + will be excluded.

Attachments

readout_NCT00001568_2024-07-23.pdf

4.5 MB

NCT00001568_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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