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

NCT00906503 | Completed Phase 1 Results

• 3 other identifiers: CDR0000642256P30CA022453WSU-2008-075
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Nodule

Keywords

pulmonary nodule

Outcome Measures

Primary Outcomes (1)

• 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).

  24-48 hours

Study Arms (1)

PET/Computed Tomography (CT)

EXPERIMENTAL

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

Drug: dexamethasone; Procedure: PET/Computed Tomography (CT); Radiation: fludeoxyglucose (18F)

Interventions

dexamethasone DRUG

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

Also known as: Decadron

PET/Computed Tomography (CT)

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

Also known as: PET Scan

PET/Computed Tomography (CT)

fludeoxyglucose (18F) RADIATION

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

Also known as: Radioactive tracer, 18F-FDG

PET/Computed Tomography (CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Sinai-Grace Hospital

Detroit, Michigan, 48235, United States

Location

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18; Radioactive Tracers

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates; Radioisotopes; Isotopes; Inorganic Chemicals; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses

Limitations and Caveats

Small number of subjects.

Results Point of Contact

• Title: Barbara Ann Karmanos Cancer Institute
• Organization: Barbara Ann Karmanos Cancer Institute

davisv@karmanos.org

313-576-9370

Study Officials

• Majid Khalaf, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 7, 2015
• Results First Posted: September 29, 2014

Record last verified: 2015-03

Locations

US (2)