Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors

Neuroendocrine Tumor Clinical Trial

Official title:

Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00569738
• Other study ID #: 061267-HMO-CTIL
• Secondary ID: Imaging of NE Tu
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2007
• Last updated: February 16, 2009
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2009
• Source: Hadassah Medical Organization
• Contact: Yodphat Krausz, MD
• Phone: 0097226776705
• Email: yodphat[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Procedure:
• PET scan with Ga68-DOTANOC
Imaging: PET scan with Ga68-DOTANOC

Locations

Country	Name	City	State
Israel	Department of Nuclear Medicine, Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,