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

NCT00123773CompletedPHASE2INTERVENTIONAL

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 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.

Key Facts

Lead Sponsor

AHS Cancer Control Alberta

Enrollment

1075

Start Date

2004-04-01

Completion Date

2008-12-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Positron Emission Tomography

Conditions

SarcomaMultiple MyelomaTesticular NeoplasmsOvarian NeoplasmsKidney Neoplasms

Eligibility

Age Range

15 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

To confirm the diagnostic effectiveness of 18F-FDG in patients with known or suspected carcinoma

Secondary Outcomes

To determine the clinical relevance of PET scans within these patient groups

Locations

Cross Cancer Institute, Edmonton, Canada

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.