Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules
This study has been completed.
Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00906503
First received: May 20, 2009
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Nodule |
Drug: dexamethasone Procedure: computed tomography Radiation: fludeoxyglucose F 18 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Does Ultra Short-term Steroid Therapy Increase the Accuracy of FDG-PET/CT in Evaluation of Pulmonary Nodules? |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Fludeoxyglucose F 18
U.S. FDA Resources
Further study details as provided by Barbara Ann Karmanos Cancer Institute:
Primary Outcome Measures:
- Feasibility of ultra short-term steroid therapy (24-48 hours) to increase the accuracy of FDG-PET/CT imaging [ Designated as safety issue: No ]
- Overall sensitivity and specificity of the nodules group [ Designated as safety issue: No ]
- Effect-size estimate [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | April 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906503
Locations
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Sinai-Grace Hospital | |
| Detroit, Michigan, United States, 48235 | |
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
| Principal Investigator: | Majid Khalaf, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00906503 History of Changes |
| Other Study ID Numbers: | CDR0000642256, P30CA022453, WSU-2008-075 |
| Study First Received: | May 20, 2009 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
pulmonary nodule |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013