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Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00123773
First received: July 22, 2005
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer Institute has recently been funded to establish a PET centre, and this study will evaluate the effectiveness, value and safety of PET scanning in a number of uncommon cancers in the Canadian health care environment.


Condition Intervention Phase
Sarcoma
Multiple Myeloma
Testicular Neoplasms
Ovarian Neoplasms
Kidney Neoplasms
 Procedure: Positron Emission Tomography
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • To confirm the diagnostic effectiveness of 18F-FDG in patients with known or suspected carcinoma

Secondary Outcome Measures:
  • To determine the clinical relevance of PET scans within these patient groups

Enrollment: 1075
Study Start Date: April 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female. (If female of child bearing potential and outside of the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.)
  • Known or suspected primary or metastatic tumours of myeloma, sarcoma, testicular carcinoma (seminomatous and non-seminomatous germ cell tumours), endometrial carcinoma, renal cell carcinoma, pancreatic adenocarcinoma, malignant mesothelioma, gastric carcinoma and cholangiocarcinoma.
  • Age equal to or greater than 15 years
  • Able and willing to follow instructions and comply with the protocol
  • Provide written informed consent prior to participation in this study
  • Karnofsky Performance Scale score 60-100

Exclusion Criteria:

  • Nursing or pregnant females
  • Having had surgery or radiotherapy within 10 days of the planned imaging study
  • Presence of a severe infection
  • Age less than 15 years
  • Blood glucose greater than 10mmol/L
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123773

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Alexander McEwan, MD Cross Cancer Institute
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00123773     History of Changes
Obsolete Identifiers: NCT00271648
Other Study ID Numbers: SP-14-0038/DX-FDG-003/21386
Study First Received: July 22, 2005
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
positron emission tomography
fluorodeoxyglucose F18
Tomography scanners, x-ray computed

Additional relevant MeSH terms:
Neoplasms
Kidney Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Ovarian Neoplasms
Testicular Neoplasms
Sarcoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
 Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 16, 2013