SPECT/CT in Endocrine and Neuroendocrine Tumors

Endocrine and Neuroendocrine Tumors Clinical Trial

Official title:

The Added Value of SPECT/CT in the Evaluation of Endocrine and Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230139
• Other study ID #: endocrineCTIL
• Status: Completed
• Phase: N/A
• First received: September 29, 2005
• Last updated: October 11, 2008
• Start date: January 2002
• Est. completion date: January 2006

Study information

• Verified date: September 2005
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The value of fusion of functional and anatomical data has been described using several fusion techniques for various nuclear medicine procedures and morphologic imaging modalities (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over the data obtained using separately performed NM study and conventional anatomic imaging as CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images will improve diagnostic accuracy and will have an impact on patient management:

Improved accuracy of NM study will improve tumor localization, the evaluation of the extent of disease and the post therapy follow up.

It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the need for more invasive procedures. It can also guide invasive procedures and radiation-therapy planning, thus improving therapy results and avoiding unnecessary treatment-related side effects.

Description:

The value of fusion of functional and anatomical data has been described using several fusion techniques for various nuclear medicine procedures and morphologic imaging modalities (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over the data obtained using separately performed NM study and conventional anatomic imaging as CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images will improve diagnostic accuracy and will have an impact on patient management:

Improved accuracy of NM study will improve tumor localization, the evaluation of the extent of disease and the post therapy follow up.

It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the need for more invasive procedures. It can also guide invasive procedures and radiation-therapy planning, thus improving therapy results and avoiding unnecessary treatment-related side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2006
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient referred for NM scintigraphy to assess the presence of endocrine or neuroendocrine tumors.

• Patient signed informed consent

Exclusion Criteria:

• The study will not be performed in pregnant or lactating women.

• Patient will not be able or willing to tolerate the scan until its completion.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoid Tumor
• Endocrine and Neuroendocrine Tumors
• Neuroendocrine Tumors

Intervention

Device:
• SPECT/CT

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of imaging modality on patient management			Yes
Secondary	The impact of imaging modality on patient management			Yes