11C-Acetate PET/CT Non-FDG-Avid Tumors

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00687778
• Other study ID #: TASMC-08-EE-109-CTIL
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2008
• Last updated: May 30, 2008
• Start date: May 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Einat Even-Sapir, MD, PhD
• Phone: 972-3-697-3536
• Email: evensap[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

F18-FDG is the widely used PET tracer in the routine practice of oncologic disease imaging using the technology of PET-CT. However, FDG-avidity is a characteristic of the individual tumor. There are various types of human malignancies, which are not taking FDG in access. In these cases FDG is not a sensitive tracer of imaging. In search for other tumor PET tracers, C11-Acetate has been shown recently in a few early studies to have a potential value in imaging of non-FDG-avid tumors.

The purpose of the current study is to assess the role of 11C-acetate PET in various tumors, which often are not detected by 18F-FDG and were not widely assessed until now.

Description:

Recent publications have suggested the use of 11C-acetate as another PET tracer for tumor imaging. The accumulation of 11C-acetate in tumor cells is related to the highly active lipid metabolism in the cell membrane associated with tumor growth. 11C-acetate is channeled into the tricarboxylic acid cycle via acetyl coenzyme A and then incorporated via phosphatidylcholine into the cell membrane's phopholipids. Possible biochemical paths of acetate incorporation or accumulation include (a) entering the Krebs cycle from acetyl coenzyme A (acetyl CoA) or as an intermediate metabolite, (b) esterification to form acetyl CoA as a major precursor in ß-oxidation for fatty acid synthesis, (c) combining with glycine in heme synthesis, and (d) through citrate for cholesterol synthesis. Of all of these possible metabolic pathways, participation in free fatty acid (lipid) synthesis is believed to be the dominant method of incorporation in tumors.

The clinical data on the role of 11C-acetate PET in human tumors is being accumulated. Most clinical studies have investigated the role of 11C-acetate PET in detection of prostate cancer. 11C-acetate PET was found valuable in the detection of recurrent prostate cancer, both in the prostate bed, lymph nodes and distant metastases. The main advantage of 11C-acetate is that it does not show physiological accumulation in the urinary bladder as is the case with 18F -FDG and therefore may be appropriate for the detection of active pelvic disease.

Comparing the uptake of 18F-FDG and of 11C-acetate in patients with lung carcinoma, the latter was found superior in the identification of a bronchiolo-alveolar carcinoma which often show no intense FDG uptake.

In the case of hepatic masses, well-differentiated HCC tumors were detect by 11C-acetate while poorly differentiated types were detected by 18F-FDG.

These data suggest that 11C-acetate PET may be valuable in the detection of well-differentiation slow growing tumors and may have a complementary role to the routinely used 18F-FDG.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients with newly diagnosed tumors, which are often non-FDG avid or show only low intensity uptake:

• Soft tissue sarcomas

• well-differentiated thyroid cancer

• well-differentiated and bronchoalveolar lung cancer

• indolent lymphomas

• neuroendocrine tumors

• GIST

• uterine malignancies

• mucin-producing cancer

• teratoma

• hepatoma

• HCC

• lobular breast carcinoma

• Patients over the age of 18

Exclusion Criteria:

• patients under the age of 18 years

• pregnant and lactating women

• claustrophobic patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma
• Carcinoma, Hepatocellular
• Carcinoma, Lobular
• GIST
• Indolent Lymphoma
• Lung Cancer
• Neuroendocrine Tumors
• Sarcoma
• Soft Tissue Sarcomas
• Teratoma
• Thyroid Cancer
• Thyroid Neoplasms
• Uterine Malignancies

Locations

Country	Name	City	State
Israel	Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of C11-Acetate and F18-FDG in tumor will be measured in SUV PET units		At completion of acuisition	No