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

Primary Purpose

Pulmonary Nodule

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dexamethasone
PET/Computed Tomography (CT)
fludeoxyglucose (18F)
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Nodule focused on measuring pulmonary nodule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute
  • Sinai-Grace Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/Computed Tomography (CT)

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 20, 2009
Last Updated
March 18, 2015
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00906503
Brief Title
Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules
Official Title
Does Ultra Short-term Steroid Therapy Increase the Accuracy of FDG-PET/CT in Evaluation of Pulmonary Nodules?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule
Keywords
pulmonary nodule

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/Computed Tomography (CT)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
Intervention Type
Procedure
Intervention Name(s)
PET/Computed Tomography (CT)
Other Intervention Name(s)
PET Scan
Intervention Description
Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose (18F)
Other Intervention Name(s)
Radioactive tracer, 18F-FDG
Intervention Description
Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
Primary Outcome Measure Information:
Title
Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Khalaf, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Sinai-Grace Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States

12. IPD Sharing Statement

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

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