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

Barbara Ann Karmanos Cancer Institute

Status and phase: Completed; Phase 1

Conditions: Pulmonary Nodule

Treatments: Procedure: PET/Computed Tomography (CT); Drug: dexamethasone; Radiation: fludeoxyglucose (18F)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00906503

WSU-2008-075

P30CA022453 (U.S. NIH Grant/Contract)

CDR0000642256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

PET/Computed Tomography (CT)

Experimental group

Description:

Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Treatment:

Radiation: fludeoxyglucose (18F)

Drug: dexamethasone

Procedure: PET/Computed Tomography (CT)