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Completed

NCT Number: NCT00906503

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

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.

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Key information

Conditions

Pulmonary Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Other names: Decadron

PET/Computed Tomography (CT)

Procedure

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

Other names: PET Scan

fludeoxyglucose (18F)

Radiation

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

Other names: Radioactive tracer, 18F-FDG

Primary outcomes

  1. Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Does Ultra Short-term Steroid Therapy Increase the Accuracy of FDG-PET/CT in Evaluation of Pulmonary Nodules?

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 21, 2009
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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