Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors

NCT ID: NCT00569738

Last Updated: 2009-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

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.

Conditions

Neuroendocrine Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A

patients with neuroendocrine tumors

PET scan with Ga68-DOTANOC

Intervention Type: PROCEDURE

Imaging: PET scan with Ga68-DOTANOC

Interventions

PET scan with Ga68-DOTANOC

Imaging: PET scan with Ga68-DOTANOC

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hadassah Medical Organization

Principal Investigators

Yodphat Krausz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Department of Nuclear Medicine, Hadassah Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yodphat Krausz, MD

Role: CONTACT

yodphat@hadassah.org.il

0097226776705

Facility Contacts

Arik Tzukert, DMD

Role: primary

arik@hadassah.org.il

0097226776095

Hadas Lemberg, PhD

Role: backup

lhadas@hadassah.org.il

0097226777572

Other Identifiers

Imaging of NE Tumors

Identifier Type: -

Identifier Source: secondary_id

061267-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id