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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pulmonary Nodule

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Trial Information

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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of ultra short-term steroid therapy (24-48 hours) to increase the accuracy of FDG-PET/CT imaging

Safety Issue:

No

Principal Investigator

Majid Khalaf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000642256

NCT ID:

NCT00906503

Start Date:

April 2009

Completion Date:

April 2012

Related Keywords:

  • Pulmonary Nodule
  • pulmonary nodule
  • Lung Neoplasms

Name

Location

Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Sinai-Grace Hospital Detroit, Michigan  48235