18F-fluorocholine and 18F-fluoride PET in Prostate Cancer

NCT04340765 | Completed DMC

• 1 other identifier: IRB106-65-A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer remains to be a public health problem around the world. For patients with prostate cancer, diphosphonate bone scintigraphy (BS) and pelvic tomographic imaging are major imaging tools to evaluate the disease spread. However, the conventional image modalities have only limited sensitivity and specificity. New imaging tracer with 18F-fluorocholine (18F-FCH) and old radiopharmaceuticals with NaF has showed promising results in detecting prostate cancers over bone scan. Nevertheless, the diagnostic performance of each tool has less been compared. The goal of this study is to compare the diagnostic performance of 18F-FCH PET/CT and NaF PET/CT for prostate cancer patients. The investigators prospectively enroll patients with the pathological diagnosis of prostate cancer and intended to receive radionuclide bone image. The patients will receive NaF PET/CT and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for cancer spreading. The reference standard will be a combination of tissue correlation, imaging, laboratory and clinical data. Diagnostic performance of both PET/CT scans will be measured and calculated.

Conditions

Prostate Cancer; Fluorocholine

Keywords

Prostate cancer; NaF; Bone scan; 18F-Fluorocholine; PET

Outcome Measures

Primary Outcomes (2)

• The sensitivities of 18F-fluorocholine PET/CT and NaF PET/CT

  The lesion-based sensitivities of these two image modalities (The number of true positive image findings/The number of confirmed metastasis)

  6 weeks

• The specificities of 18F-fluorocholine PET/CT and NaF PET/CT

  The lesion-based specificities of these two image modalities (The number of true negative image findings/The number of confirmed e benign lesion)

  6 weeks

Secondary Outcomes (1)

• Extraskeletal metastatic lesions detected by 18F-fluorocholine PET/CT

  6 weeks

Study Arms (1)

18F-fluorocholine PET/CT

EXPERIMENTAL

18F-fluorocholine PET/CT

Drug: 18F-fluorocholine

Interventions

18F-fluorocholine DRUG

Dual phase 18F-fluorocholine PET/CT

Also known as: 18F-NaF

18F-fluorocholine PET/CT

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are pathologically diagnosed with prostate adenocarcinoma.
• Received NaF PET/CT.

You may not qualify if:

• Diagnosed to have multiple cancers
• Younger than 20-year-old
• Known allergic to investigational drug
• The patients is classified as not suited for the exam by the investigators.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluorocholine

Condition Hierarchy (Ancestors)

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

Study Officials

• Yu-Hung Chen, M.D.

  Hualien Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will receive both 18F-fluorocholine PET and NaF PET

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: February 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)