Clinical trial NCT00906503: Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules
Official title: Does Ultra Short-term Steroid Therapy Increase the Accuracy of FDG-PET/CT in Evaluation of Pulmonary Nodules?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Nodule
Keywords: pulmonary nodule
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

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-PET/CT) imaging in categorizing nodules in patients with pulmonary nodules.
* To calculate the overall sensitivity and specificity of the nodules group, based on FDG uptake, for predicting malignancy.
* To gather effect-size estimates that will be used to improve the quality of a larger follow-up study.

OUTLINE: Patients receive oral dexamethasone at 40, 28, 16, and 4 hours before imaging. Patients undergo fludeoxyglucose F 18 (FDG)-positron emission tomography/computed tomography (PET/CT) imaging at baseline and upon completion of steroid therapy.

After completion of study therapy, patients are followed for 6 months.

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

Primary outcomes:
measure: Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging
timeFrame: 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Sinai-Grace Hospital
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Majid Khalaf, MD
role: PRINCIPAL_INVESTIGATOR
References: