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

May 30, 2008 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Tel Aviv, Israel, 64239
    - Recruiting
    - Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
    - Contact:
      
      Einat Even-Sapir, MD, PhD
      
      Phone Number: 972-3-697-3536
      
      Email: evensap@tasmc.health.gov.il
    - Contact:
      
      Limor Zuriel, MSc
      
      Phone Number: 972-3-697-3536
      
      Email: limorz@tasmc.health.gov.il

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 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 and lobular breast carcinoma.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 100 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 and lobular breast carcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Uptake of C11-Acetate and F18-FDG in tumor will be measured in SUV PET units Time Frame: At completion of acuisition	At completion of acuisition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator: Einat Even-Sapir, MD, PhD, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Estimate)