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

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.

• dexamethasone (Drug), also known as Decadron: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
• PET/Computed Tomography (CT) (Procedure), also known as PET Scan: Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
• fludeoxyglucose (18F) (Radiation), also known as Radioactive tracer, 18F-FDG: Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Primary outcomes

• Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging [24-48 hours]: The blood glucose of all patients will be checked by accu-check before the injection of 18F-FDG. The acceptable blood glucose level will be ≤120 mg/dl. Any participant experienced elevated fasting blood glucose of more than 120 mg/dl after steroid therapy, he /she will be asked to come back to the PET center within 48 hours to check the blood glucose level. If the blood glucose level did not decline to baseline level, the participant will be asked to follow with his/her family doctor for management. Participants with history of systemic hypertension will be monitored for increased blood pressure. After 50-to-70 minutes period for FDG incorporation into presumed lesions, patient will under go a limited 18F-FDG PET/CT for the area of the interest (1-2 bed positions). PET imaging will be performed using a GE Discovery STE PET/CT system (GE Medical Systems, Milwaukee, WI).

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging (Primary), Mean, gm/ml: PET/Computed Tomography (CT) 3.97 +/- 3.81

Adverse events

Limitations and caveats: Small number of subjects.

• Majid Khalaf, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute

NIH grants: P30CA022453