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Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, December 2007
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00569738
  Purpose

Imaging of neuroendocrine tumors (NETs) relies on conventional morphological methods and on somatostatin receptor scintigraphy (SRS). SRS is effective for carcinoid tumors, and for most pancreatic islet-cell tumors, but may fail to detect some tumors. Furthermore, this technique may require repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs such as DOTANOC improves lesion detection. In addition, labeling with Ga68 and use of PET/CT improves the pharmacokinetics of the tracer resulting in better tumor visualization, and an easier procedure with imaging over only 1-2 hours.

In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the imaging data to those of anatomical and other functional modalities, and to histopathology, when available.


Condition Intervention
Neuroendocrine Tumor
Procedure: PET scan with Ga68-DOTANOC

MedlinePlus related topics: Cancer Nuclear Scans
Drug Information available for: Gallium Somatostatin
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors

Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: December 2009
Groups/Cohorts Assigned Interventions
A
patients with neuroendocrine tumors
Procedure: PET scan with Ga68-DOTANOC
Imaging: PET scan with Ga68-DOTANOC

Detailed Description:

Neuroendocrine tumors (NETs), best treated by complete surgical resection, are frequently difficult to localize due to small size, presence in hollow organs, and morphological changes caused by prior surgery. Imaging of NETs relies primarily on conventional morphological methods (EUS, CT, MRI, US). Functional imaging, such as somatostatin receptor scintigraphy (SRS) using the In111-labeled somatostatin analog octreotide, provides better staging of the disease, visualization of occult tumor, and evaluation of patient eligibility for somatostatin analog treatment. This modality is effective for carcinoid tumors, and for most pancreatic islet-cell tumors. However, it may fail to detect some tumors, mostly due to low density of somatostatin receptors, with resulting lack of tumor uptake. The relatively poor spatial resolution of planar and SPECT imaging may also reduce tumor detection, particularly for small tumors and/or those with low uptake. Furthermore, this technique is lengthy, often requiring repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs such as DOTANOC offers many advantages. Higher uptake of the newer analogs in more of the somatostatin receptor subtypes improves lesion detection. In addition, labeling with the positron emitter, Ga68, instead of In111 improves the pharmacokinetics of the tracer, and the faster tumor uptake and more rapid clearance from normal tissues increases tumor to background contrast, improving tumor visualization, and resulting in an easier procedure with imaging only 1-2 hours after tracer injection. The superior spatial resolution of positron emission tomography (PET) again enhances lesion detectability, and use of PET makes it possible to perform exact quantitation of tracer uptake that can be useful for monitoring therapy and for planning peptide receptor radionuclide therapy.

In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the imaging data to those of anatomical and other functional modalities, and to histopathology, when available.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

neuroendocrine tumor clinic

Criteria

Inclusion Criteria:

  • neuroendocrine tumor
  • patients who are able to lie in scanner for up to 50 minutes

Exclusion Criteria:

  • under age 18
  • pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569738

Contacts
Contact: Yodphat Krausz, MD 0097226776705 yodphat@hadassah.org.il

Locations
Israel
Department of Nuclear Medicine, Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yodphat Krausz, MD Hadassah Medical Center
  More Information

Responsible Party: Hadassah Medical Organization ( Yodphat Krausz M.D. )
Study ID Numbers: 061267-HMO-CTIL, Imaging of NE Tumors
Study First Received: December 6, 2007
Last Updated: December 6, 2007
ClinicalTrials.gov Identifier: NCT00569738  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
neuroendocrine tumor
somatostatin analog
Gallium 68
PET

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Somatostatin
Neuroendocrine Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 15, 2009