Whole Body PET-MRI in Paediatric and Adolescent Lymphoma | NCT02935348

Studies
Whole Body PET-MRI in Paediatric and Adolescent Lymphoma

NCT02935348

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Oct 17, 2016Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Lymphoma

Interventions

Whole Body MRI

Countries

United Kingdom

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

May 2017Estimated

Completion Date

May 2017Estimated

First Submitted Date

Dec 3, 2015

First Submission Date that Met QC Criteria

Oct 13, 2016

First Posted Date

Oct 17, 2016Estimated

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

Oct 13, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.

Investigators want to investigate if a combined PET-MRI scan could give the same information.

Children who join our study will have an extra scan twice during their treatment

Detailed Description

Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.

Investigators want to investigate if a combined PET-MRI scan could give the same information.

Children who join our study will have an extra scan twice during their treatment

Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole Body MRI	Radiation	Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The investigator will determine the technical feasibility of performing functional co-registered combined PET-MRI in this patient group using diffusion-weighted MR imaging.		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected or histologically confirmed Hodgkin lymphoma
Male or female participants
Age 0-20 years inclusive
Entered into the EuroNet PHL-C1 trial, LP1 trial or successor Euronet trials, including Euronet PHL C2 due to open from 2013 onwards or planned to receive chemotherapy regimens of said trials without being formally entered into the trial.
Participant/Guardian/Parental written informed consent

Exclusion Criteria:

Participants with contraindications to MRI (including cardiac pacemakers or non-MRI compatible intracranial vascular clips)
Participants who are pregnant or nursing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Childhood and adolescent cases of clinically suspected or histologically confirmed Hodgkin Lymphoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joey J Clemente	Contact	02034479094	79094	joey.clemente@uclh.nhs.uk

Overall Officials

Name	Affiliation	Role
Paul Humphries	UCL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Medical Imaging	Recruiting	London	London	NW1 2PG	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided