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

NCT ID: NCT00906503

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-04-30

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.

Conditions

Pulmonary Nodule

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET/Computed Tomography (CT)

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

Group Type: EXPERIMENTAL

dexamethasone

Intervention Type: DRUG

Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan

PET/Computed Tomography (CT)

Intervention Type: PROCEDURE

Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

fludeoxyglucose (18F)

Intervention Type: RADIATION

Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Interventions

dexamethasone

Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan

Intervention Type: DRUG

PET/Computed Tomography (CT)

Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Intervention Type: PROCEDURE

fludeoxyglucose (18F)

Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Intervention Type: RADIATION

Other Intervention Names

Decadron; PET Scan; Radioactive tracer; 18F-FDG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Majid Khalaf, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Sinai-Grace Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2008-075

Identifier Type: -

Identifier Source: secondary_id

CDR0000642256

Identifier Type: -

Identifier Source: org_study_id