Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients | NCT03011749

Studies
Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients

NCT03011749

Sponsor

Rigshospitalet, Denmark

Status

Terminated

Last Update Posted

Sep 12, 2019Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Metastatic Prostate Carcinoma

Interventions

FLT PET/CT

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2018Actual

First Submitted Date

Jan 4, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to investigate whether positron emission tomography (PET) using the tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of hematological toxicity

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLT PET/CT	Experimental	FLT PET/CT	Other: FLT PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLT PET/CT	Other	FLT PET/CT before first series of Radium-223 and after 2 series	FLT PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uptake of FLT in hematological bone marrow		3 months

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of hematological toxicity		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic castration resistant prostate cancer
Eligible for Radium-223 therapy
Informed consent

Exclusion Criteria:

Inability to understand study protocol
Extensive metastatic involvement of the axial skeleton ("superscan" on bone scintigraphy)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

Not provided