NCT00687778

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 2, 2008

Status Verified

May 1, 2008

Enrollment Period

1.1 years

First QC Date

May 28, 2008

Last Update Submit

May 30, 2008

Conditions

Soft Tissue SarcomasThyroid CancerLung CancerIndolent LymphomaNeuroendocrine TumorsGISTUterine MalignanciesCarcinoma, HepatocellularCarcinoma, LobularTeratoma

Keywords

C11-AcetateFDGsarcomaMeasurement of C11-Acetate uptake in tumors which are often non-FDG avid.Soft tissue sarcomaswell-differentiated thyroid cancerwell-differentiated and bronchoalveolar lung cancerindolent lymphomas, neuroendocrine tumorsGISTuterine malignanciesmucin-producing cancerteratoma, hepatomaHCClobular breast carcinoma

Outcome Measures

Primary Outcomes (1)

  • Uptake of C11-Acetate and F18-FDG in tumor will be measured in SUV PET units

    At completion of acuisition

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • patients under the age of 18 years
  • pregnant and lactating women
  • claustrophobic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

SarcomaThyroid NeoplasmsLung NeoplasmsNeuroendocrine TumorsCarcinoma, HepatocellularCarcinoma, LobularTeratoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Einat Even-Sapir, MD, PhD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Einat Even-Sapir, MD, PhD

CONTACT

972-3-697-3536evensap@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2010

Last Updated

June 2, 2008

Record last verified: 2008-05

Locations

IL(1)