11C- and 18F-Choline PET/MR Imaging for Prostate Cancer

NCT02397408 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 145511NCI-2015-00731R01CA148708
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (11)

• Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1)

  The average K1 values of primary tumors will be reported along with the standard deviation

  Day 1

• Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max)

  The K1max values of primary tumors will be reported along with the standard deviation

  Day 1

• Average Standardized Uptake Value (SUVavg)

  The SUVavg values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy

  Day 1

• Mean of the Standardized Uptake Value (SUVmax)

  The SUVmax values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy.

  Day 1

• Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging

  Sensitivity (True Positive Rate, TPR) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher sensitivity to identify the prostate cancer using SUVmax . The sensitivity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported.

  Day 1

• Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging

  Specificity (True Negative Rate) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher specificity to identify the prostate cancer using SUVmax. The specificity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported.

  Day 1

• Correlation of K1 of Primary Tumors With K1max

  A spearman rank correlation test was performed to test the correlation of K1 with K1max. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

  Day 1

• Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg)

  A spearman rank correlation test was performed to test the correlation of K1 with the SUVavg of primary tumors. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

  Day 1

• Correlation of K1max of Primary Tumors With SUVmax

  A spearman rank correlation test was performed to test the correlation of K1max with SUVmax. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

  Day 1

• Correlation of K1max of Primary Tumors With SUVavg

  A spearman rank correlation test was performed to test the correlation of K1max with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

  Day 1

• Correlation of SUVmax of Primary Tumors With SUVavg

  A spearman rank correlation test was performed to test the correlation of SUVmax with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks.

  Day 1

Secondary Outcomes (4)

• Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level

  Day 1

• Correlation of SUVmax of Primary Tumors With Pathological Stage

  Day 1

• Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores

  After surgery, Up to 6 months

• Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups

  After surgery, Up to 6 months

Study Arms (1)

Diagnostic 11C- and 18F-choline PET/MR imaging

EXPERIMENTAL

Patients are given 370 megabecquerel (MBq) 11C-Choline (11C) intravenously and 3 MBq/kg 18F-Choline (18F) intravenously prior to a whole-body PET/MR imaging

Drug: Carbon C 11 Choline; Drug: Fluorine F 18 Choline; Procedure: Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)

Interventions

Carbon C 11 Choline DRUG

Given intravenously (IV) prior to imaging

Also known as: C-11 Choline, Ethanaminium, 2-hydroxy-N,N-dimethyl-N-(methyl-11C)-

Diagnostic 11C- and 18F-choline PET/MR imaging

Fluorine F 18 Choline DRUG

Given intravenously (IV) prior to imaging

Also known as: 18F-Fluorocholine, [18F]-Choline

Diagnostic 11C- and 18F-choline PET/MR imaging

Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI) PROCEDURE

Undergo whole-body PET/MR imaging

Also known as: PET/MRI, Whole-body PET/MR imaging

Diagnostic 11C- and 18F-choline PET/MR imaging

Eligibility Criteria

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

You may qualify if:

• Age: Patients must be \>=18 years of age
• Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound.
• Disease Status: Unfavorable intermediate to high-risk prostate cancer, per the Cancer of the Prostate Risk Assessment Score (CAPRA) (CAPRA 5-10)
• Karnofsky Performance Status \>=70
• Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan
• Planned to undergo radical prostatectomy and extended pelvic lymph node dissection
• Adequate bone marrow and organ function defined as follows:
• Adequate bone marrow function:
• Leukocytes \>= 3,000/microliter (mcL)
• Absolute Neutrophil Count \>= 1,500/mcL
• Platelets \>= 100,000/mcL
• Adequate hepatic function:
• Total bilirubin - within normal institutional limits
• Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) \<= 2.5 X institutional upper limit of normal
• Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<= 2.5 X institutional upper limit of normal

You may not qualify if:

• Participation would significantly delay the scheduled standard of care therapy
• Karnofsky performance status of \< 60
• Inadequate venous access
• Administered a radioisotope within 5 physical half lives prior to study enrollment
• Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (1)

• Choi JY, Yang J, Noworolski SM, Behr S, Chang AJ, Simko JP, Nguyen HG, Carroll PR, Kurhanewicz J, Seo Y. 18F Fluorocholine Dynamic Time-of-Flight PET/MR Imaging in Patients with Newly Diagnosed Intermediate- to High-Risk Prostate Cancer: Initial Clinical-Pathologic Comparisons. Radiology. 2017 Feb;282(2):429-436. doi: 10.1148/radiol.2016160220. Epub 2016 Aug 11.

  PMID: 27513849 RESULT

Related Links

• Link to Publication for NCT02397408

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluorocholine; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

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)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Albert J. Chang, MD, PhD
• Organization: University of California, Los Angeles

ajchang@mednet.ucla.edu

(310) 82509771

Study Officials

• Albert J Chang, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 25, 2015
• Study Start: April 9, 2015
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)