MedDataX Logo

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

NCT ID: NCT00687778

Last Updated: 2008-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dept of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Einat Even-Sapir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Einat Even-Sapir, MD, PhD

Role: CONTACT

Phone: 972-3-697-3536

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Einat Even-Sapir, MD, PhD

Role: primary

Limor Zuriel, MSc

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TASMC-08-EE-109-CTIL

Identifier Type: -

Identifier Source: org_study_id