Pulmonary Nodule
Conditions
Keywords
pulmonary nodule
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.
Interventions
DRUGdexamethasone
Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
PROCEDUREPET/Computed Tomography (CT)
Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
RADIATIONfludeoxyglucose (18F)
Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
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
fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | PET/Computed Tomography (CT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging
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).
Time frame: 24-48 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PET/Computed Tomography (CT) | Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging | Malignant nodules | 3.97 gm/ml | Standard Deviation 3.81 |
| PET/Computed Tomography (CT) | Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging | Benign nodules | 4.27 gm/ml | Standard Deviation 2.8 |
95% CI: [0.06, 31.1]