Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer

NCT00123760 | Completed Phase 2

• 1 other identifier: SP-11-0035/DX-FDG-001/21221
• Study Type: interventional
• Target: 10,838
• Locations: 1 country
• Sites: 1

Brief Summary

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 (CCI) has recently been funded to establish a PET centre, and this study will prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications.

Conditions

Brain Neoplasms; Lung Neoplasms; Thyroid Neoplasms; Colorectal Neoplasms; Lymphoma

Keywords

Positron-Emission Tomography; Fluorodeoxyglucose F18; Tomography scanners, X-Ray computed

Outcome Measures

Primary Outcomes (1)

• To demonstrate the safety of 18F-FDG synthesized from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit (ASU) in the Edmonton PET Centre facility

  One Year

Secondary Outcomes (1)

• To confirm the diagnostic effectiveness of 18F-FDG in subjects with known or suspected oncologic disease and compare this to literature values

  One Year

Interventions

Positron Emission Tomography (PET) scan PROCEDURE

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Nursing or pregnant females
• Presence of a severe infection
• Age less than 15 years
• Having had surgery or radiotherapy within 10 days of the planned imaging study

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms; Lung Neoplasms; Thyroid Neoplasms; Colorectal Neoplasms; Lymphoma

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alexander McEwan, MB, MSc, MD, FRCP

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2005
• First Posted: July 26, 2005
• Study Start: February 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 25, 2016

Record last verified: 2012-03

Locations

CA (1)