NCT02969564

Brief Summary

The number of metastases in a patient with primary or recurrent prostate cancer has major prognostic implication. The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for determining the presence or absence of bone lesions in prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold standard will be a combination of clinical follow-up, additional imaging and biopsy, as indicated by the multidisciplinary discussion at the tumor board. The findings from whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

April 21, 2016

Last Update Submit

November 2, 2020

Conditions

Bone MetastasesProstate Cancer

Keywords

prostate cancerbone metastasesPET/MRI

Outcome Measures

Primary Outcomes (1)

  • Compare the diagnostic performance of 18F-NaF-PET/MR scanning to that of whole body 99mTc-MDP-SPECT/CT for detecting cancer that has spread to the bone (bone metastasis)

    the primary measure will be differences in the area under the curves (AUC) of the receiver operating characteristic (ROC) curves that will be generated from the interpretations of each technology.

    through study completion, an average of 2 years

Secondary Outcomes (2)

  • To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.

    through study completion, an average of 2 years

  • To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities.

    through study completion, an average of 2 years

Study Arms (1)

prostate cancer patient, with up to five metastases

prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.

Other: scintigraphy 99mTc-MDP-SPECT/CT.Other: 18F-NaF-PET/MR

Interventions

scintigraphy 99mTc-MDP-SPECT/CT.OTHER

SPECT/CT will be performed for every patient in the frame of their clinical follow up

prostate cancer patient, with up to five metastases
18F-NaF-PET/MROTHER

a 18F-NaF-PET/MR will be performed, in the frame of this clinical study, to the patients to assess the difference of sensitivity of the 2 exams

prostate cancer patient, with up to five metastases

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Oligo- metastatic patient with prostate cancer and bone lesions (up to five metastases)

You may qualify if:

  • Oligo- metastatic patient with prostate cancer and bone lesions (up to five metastases) based on scintigraphy and whole-body SPECT/CT (staging or recurrence).
  • Patient must be able to provide informed consent.
  • Patient is ≥ 18 years old

You may not qualify if:

  • Patient with another active malignancy.
  • Patient is \< 18 years old
  • Patients with contraindications of MRI procedure (metal implants, cardiac pacemakers, old type of prosthesis)
  • Patients with severe renal impairment (MDRD \< 30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2016

First Posted

November 21, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

September 14, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

CH(1)