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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


Phase 2
N/A
N/A
Not Enrolling
Both
Colorectal Neoplasm

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Trial Information

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


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 proposed as a way of
localizing disease in these patients. This study will evaluate the sensitivity,
specificity, accuracy and predictive value of FDG-PET scans and anti-CEA immunoscintigraphy
in patients following resection of colorectal carcinoma who have rising serum CEA values in
the absence of imageable disease by conventional modalities. Patients who meet inclusion
criteria will undergo FDG-PET scan and anti-CEA immunoscintigraphy followed by an
exploratory laparotomy. Abdominal explorations will be conducted by two surgeons, one of
whom will be blinded to the results of the FDG-PET and CEA scans. All suspicious lesions
will be biopsied and if possible resected. Results at operation will be correlated with the
results of the scans. The goal of the study is to determine the role of FDG-PET scanning
and anti-CEA immunoscintigraphy in the localization of recurrent colorectal carcinoma in
patients with rising serum CEA levels.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

970068

NCT ID:

NCT00001568

Start Date:

February 1997

Completion Date:

October 2002

Related Keywords:

  • Colorectal Neoplasm
  • Tumors
  • Detection
  • Follow-Up
  • Markers
  • Radiolabeled
  • Neoplasms
  • Carcinoma
  • Colorectal Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892