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

2014-08-27 03:59:32 | BioPortfolio


Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region.

For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit.

Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan.

At the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed.

Patients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.


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.

Study Design

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


Colorectal Neoplasm




National Cancer Institute (NCI)
United States




National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:59:32-0400

Clinical Trials [1410 Associated Clinical Trials listed on BioPortfolio]

Correlation Between Various Adipokines and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG) (18FDG-PET)

The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenos...

Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies

Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand,...

Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.

Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation

The objective of the study is to investigate the evolution ofn 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with lung cancer of during ...

5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as 5-fluoro-2'-deoxycytidine and tetrahydrouridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by ...

PubMed Articles [1926 Associated PubMed Articles listed on BioPortfolio]

Risk Factors of Post-Endoscopic Submucosal Dissection Electrocoagulation Syndrome for Colorectal Neoplasm.

Colorectal endoscopic submucosal dissection (ESD) is used for the treatment of large colorectal superficial neoplasms. However, there have been no large studies on electrocoagulation syndrome developi...

Flexible sigmoidoscopy in colorectal cancer screening: implications of different colonoscopy referral strategies.

Flexible sigmoidoscopy (FS) screening reduces colorectal cancer incidence and mortality. Its potential to detect proximal neoplasms depends on colonoscopy referral. We estimated diagnostic performance...

Organocatalytic Enantioselective Synthesis of α-Fluoro-β-amino Acid Derivatives.

Asymmetric cyclocondensation of N-sulfonylimines with fluoroacetic acid promoted by isothiourea catalyst HBTM-2 generates 3-fluoro-β-lactams with high enantio- and diastereoselectivity. These reactiv...

PET/CT and prediction of thyroid cancer in patients with follicular neoplasm or atypia.

To examine whether addition of F-fluoro-deoxy-glucose positron emission tomography/computed tomography (FDG-PET/CT) to fine needle aspiration biopsy (FNAB) would improve prediction of thyroid cancer i...

Efficacy of autofluorescence imaging for flat neoplasm detection: a multicenter randomized controlled trial (A-FLAT trial).

Colorectal flat (nonpolypoid) lesions can be overlooked during colonoscopy. This study evaluated the efficacy of updated autofluorescence imaging (AFI) for detecting colorectal flat neoplasms.

Medical and Biotech [MESH] Definitions

Clusters of colonic crypts that appear different from the surrounding mucosa when visualized after staining. They are of interest as putative precursors to colorectal adenomas and potential biomarkers for colorectal carcinoma.

Abnormal growths of tissue that follow a previous neoplasm but are not metastases of the latter. The second neoplasm may have the same or different histological type and can occur in the same or different organs as the previous neoplasm but in all cases arises from an independent oncogenic event. The development of the second neoplasm may or may not be related to the treatment for the previous neoplasm since genetic risk or predisposing factors may actually be the cause.

Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.

Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).

2-Deoxy-D-arabino-hexose. An antimetabolite of glucose with antiviral activity.

More From BioPortfolio on "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"

Quick Search


Relevant Topic

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Searches Linking to this Trial