Status:
COMPLETED
Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pulmonary Nodule
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before and after steroid therapy may help doctors assess a patient's response to treatment and help plan the best tr...
Detailed Description
OBJECTIVES: * To determine whether ultra short-term steroid therapy (24-48 hours) can be used to increase the accuracy of fludeoxyglucose F 18 positron emission tomography/computed tomography (FDG-PE...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Presence of ≥ 1 measurable pulmonary nodule (1.0-3.0 cm) suggestive of malignancy or chronic inflammatory process on positron emission tomography (PET) scan
- No lesions consistent with malignancy or inflammation according to history, PET findings, or biopsy
- Baseline scan average time between injection and start of scan within 50-70 min
- Mean liver standardized uptake value (SUV) of baseline scan normal
- No sign of significant partial paravenous tracer administration in the images of baseline scan
- No lung nodule(s) suggestive of lymphoma
- No lung lesions suggestive of tuberculosis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Blood glucose levels ≤ 150 mg/100 mL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to tolerate PET/CT imaging
- No history of diabetes
- No poorly controlled hypertension
- No prior malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ, or other cancer from which the participant has been disease free for \< 3 years
- No active malignancy within the past 5 years
- PRIOR CONCURRENT THERAPY:
- More than 5 years since prior chemotherapy or radiotherapy
- No concurrent steroids
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00906503
Start Date
April 1 2009
End Date
April 1 2012
Last Update
April 7 2015
Active Locations (2)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
2
Sinai-Grace Hospital
Detroit, Michigan, United States, 48235