Phase 1 N=9 Diagnostic

Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules

Pulmonary Nodule

Bottom Line

View on ClinicalTrials.gov: NCT00906503 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging — 3.97; 4.27 gm/ml

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: dexamethasone (Drug); PET/Computed Tomography (CT) (Procedure); fludeoxyglucose (18F) (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Barbara Ann Karmanos Cancer Institute
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging	3.97; 4.27	—

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 treatment. PURPOSE: This phase I trial is studying fludeoxyglucose F 18 PET scan performed before and after ultra short-term dexamethasone therapy to see how well it measures changes in nodules in patients with lung nodules.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00906503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.