18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR

Solid Tumor, Adult Clinical Trial

Official title:

Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717572
• Other study ID #: 201508093
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2016
• Est. completion date: June 5, 2017

Study information

• Verified date: April 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad population of patients with malignant solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 5, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with histologically confirmed malignant solid tumors (local or metastatic, newly diagnosed or recurrent disease).

• Patient must have at least one lesion measuring = 2.0 cm.

• 18 years of age or older.

• Ability to provide informed consent.

Exclusion Criteria:

• Cancer therapy within 30 days of baseline imaging.

• Uncontrolled intercurrent illness including, but not limited to active infections.

• Patients with insulin-dependent diabetes.

• Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants.

• Patients who are pregnant or nursing.

• Inability to tolerate 60 minutes of PET imaging.

• Inability to comply with study procedures.

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Radiation:
• Fludeoxyglucose F 18

Device:
• Positron Emission Tomography

• Computerized Tomography

• Magnetic Resonance Imaging

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of repeated quantitative measures of FDG uptake as measured by SUVmax	-SUVmax is the maximum standardized uptake value (SUV) of the area of showing metabolic activity and this is used to show response	Completion of study (up to Day 7)
Primary	Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak	-SUVpeak, which is defined as the average SUV within a 1 cubic cm volume within the region of the tumor with the highest metabolic activity	Completion of study (up to Day 7)
Primary	Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC	DW MRI is a method of mapping the diffusion process of water within and between tissues; Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)	Completion of study (up to Day 7)
Primary	Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC	DW MRI is a method of mapping the diffusion process of water within and between tissues; Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)	Completion of study (up to Day 7)
Secondary	Evaluation of the ratio of SUVmax and ADCmin		Completion of study (up to Day 7)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine