18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy... | NCT05826158

Studies
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma

NCT05826158

Sponsor

Rigshospitalet, Denmark

Status

Recruiting

Last Update Posted

Nov 15, 2024Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Neuroblastoma

Interventions

18FmFBG imaging on the Large Field of View PET/CT (Total body 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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2022Actual

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Apr 11, 2023

First Submission Date that Met QC Criteria

Apr 11, 2023

First Posted Date

Apr 24, 2023Actual

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

Nov 13, 2024

Last Update Posted Date

Nov 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of neuroblastoma

Detailed Description

This is a prospective study designed to assess the use of 18F-mFBG PET imaging compared to 123I-mIBG scintigraphy in subjects with known or presumed neuroblastoma. Eligible participants will have either histopathologically established diagnosis of neuroblastoma or a presumed diagnosis based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results.

Subjects will only be administered 18F-mFBG if they have undergone or are scheduled to undergo a 123I-mIBG within +/- 7 days of the date of the 18F-mFBG scan. Subjects should not have received any chemotherapy, immunotherapy or radiotherapy between the clinical and 18F-mFBG imaging studies.

18F-mFBG PET studies will be evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.

The clinical 123I-mIBG is also evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.

Blinded readers will record whether findings on 18F-mFBG and 123I-mIBG scans are consistent with neuroblastoma.

Subject-level diagnostic performance will be assessed on the basis of differencies in lesion-counting between the blinded 18F-mFBG scan interpretation and the 123I-mIBG scan. In case of discrepancy, independently assessed by an Expert Panel.

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with Neuroblastoma	Other		Diagnostic Test: 18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)	Diagnostic Test	18F-mFBG imaging on the Large Field of View PET/CT (Total body PET/CT)	Children with Neuroblastoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
18F-mFBG PET Scan identification of Neuroblastoma on the LAFOV PET/CT	Pathological 18F-mFBG uptake when imaging after 60 minutes with LAFOV PET/CT	60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Comparison of 18F-mFBG with Clinical 123I-mIBG imaging	Pathological uptake on 18F-mFBG will be compared with pathological uptake on 123I-mIBG, lesions based comparison	7 days apart

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrolment in the trial; OR b) A presumed diagnosis of neuroblastoma based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results, including individuals in whom therapy has already been empirically initiated.
The subject has undergone or is scheduled to undergo evaluation of neuroblastoma disease status, including 123I-mIBG +/- 7 days to the date of 18F-mFBG imaging, with no therapy between such evaluation.
Ability of subject or subject's legal guardian to understand and sign a written informed consent document.

-

Exclusion Criteria:

1. Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise Borgwardt, MD, PhD.	Contact	+4535459568		lise.borgwardt@regionh.dk

Overall Officials

Name	Affiliation	Role
Lise Borgwardt, MD, PhD.	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Copenhagen University Hospital	Recruiting	Copenhagen		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38960713	Derived	Borgwardt L, Brok J, Andersen KF, Madsen J, Gillings N, Fosbol MO, Denholt CL, Petersen IN, Sorensen LS, Enevoldsen LH, Oturai PS, Johannesen HH, Hojgaard L, Schulze C, Saxtoft E, Andersen F, Fischer BM. Performing [18F]MFBG Long-Axial-Field-of-View PET/CT Without Sedation or General Anesthesia for Imaging of Children with Neuroblastoma. J Nucl Med. 2024 Aug 1;65(8):1286-1292. doi: 10.2967/jnumed.123.267256.

ID	Term
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors