NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT02429804 | Terminated Phase 1 DMC

• 5 other identifiers: PROS0063NCI-2015-00553ep 3265396754P30CA124435
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to hormone therapy and has spread to other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors accurately measure how well patients respond to treatment with radium Ra 223 dichloride.

Conditions

Hormone-Resistant Prostate Cancer; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Carcinoma

Outcome Measures

Primary Outcomes (5)

• Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity

  Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.

  24 weeks

• Dichotomized treatment response at 24 weeks, based on computed tomography (CT) lesion size

  Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.

  24 weeks

• Dichotomized treatment response at 24 weeks, based on alkaline phosphatase (ALP) measurements (per lesion analysis)

  Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.

  24 weeks

• Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value

  12 weeks

• Percent reduction at 12 weeks in MRI lesion size (per lesion analysis)

  12 weeks

Secondary Outcomes (2)

• Presence of new or regrowing extra-skeletal disease at 12 and/or 24 weeks on NaF/FDG PET/MRI that is not present on corresponding standard-of-care 99mTc-MDP bone scintigraphy and CT (per lesion analysis)

  Up to 24 weeks

• True status (true positive or false positive) of such lesions after 12 months of follow-up, based on all information except NaF/FDG PET/MRI (per lesion analysis)

  12 months

Study Arms (1)

Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)

EXPERIMENTAL

Patients receive 18F NaF and 18F FDG IV over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223.

Procedure: Contrast-enhanced Magnetic Resonance Imaging; Drug: Fludeoxyglucose F-18; Drug: Fluorine F 18 Sodium Fluoride; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Contrast-enhanced Magnetic Resonance Imaging PROCEDURE

Undergo contrast-enhanced MRI

Also known as: CONTRAST ENHANCED MRI, Contrast-enhanced MRI

Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)

Fludeoxyglucose F-18 DRUG

Given IV

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)

Fluorine F 18 Sodium Fluoride DRUG

Given IV

Also known as: 18 F-NaF, F-18 NaF

Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)

Positron Emission Tomography PROCEDURE

Undergo PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides written informed consent
• Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride)
• Able to remain still for duration of the imaging procedure (about one hour)

You may not qualify if:

• Metallic implants

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Andrei Iagaru

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)