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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00687778
First received: May 28, 2008
Last updated: May 30, 2008
Last verified: May 2008
  Purpose

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.


Condition
Soft Tissue Sarcomas
Thyroid Cancer
Lung Cancer
Indolent Lymphoma
Neuroendocrine Tumors
GIST
Uterine Malignancies
Carcinoma, Hepatocellular
Carcinoma, Lobular
Teratoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Uptake of C11-Acetate and F18-FDG in tumor will be measured in SUV PET units [ Time Frame: At completion of acuisition ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687778

Contacts
Contact: Einat Even-Sapir, MD, PhD 972-3-697-3536 evensap@tasmc.health.gov.il

Locations
Israel
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Einat Even-Sapir, MD, PhD    972-3-697-3536    evensap@tasmc.health.gov.il   
Contact: Limor Zuriel, MSc    972-3-697-3536    limorz@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Einat Even-Sapir, MD, PhD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Einat Even-Sapir MD, PhD, Dept of Nuclear Medicine, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00687778     History of Changes
Other Study ID Numbers: TASMC-08-EE-109-CTIL
Study First Received: May 28, 2008
Last Updated: May 30, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
C11-Acetate
FDG
sarcoma
Measurement of C11-Acetate uptake in tumors which are often non-FDG avid.
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

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Lung Neoplasms
Neuroendocrine Tumors
Thyroid Neoplasms
Carcinoma, Hepatocellular
Teratoma
Lymphoma
Carcinoma
Carcinoma, Lobular
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014