F-18 FDOPA PET/CT Versus I-123 MIBG Scintigraphy With SPE... | NCT05948137

Studies
F-18 FDOPA PET/CT Versus I-123 MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma

NCT05948137

Sponsor

Asan Medical Center

Status

Terminated

Last Update Posted

Jul 17, 2023Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Pheochromocytoma
Paraganglioma

Interventions

F-18 FDOPA PET/CT

Countries

South Korea

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study had to be prematurely stopped, falling short of the initial target due to prolonged shortages in the supply of 123I-MIBG.

Expanded Access Info

Start Date

Sep 21, 2017Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Jul 7, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 17, 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

Jul 13, 2023

Last Update Posted Date

Jul 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pheochromocytomas and paragangliomas (PPGLs) are chromaffin cells-derived tomours that originate from the adrenal medulla (80~85%) and the extra-adrenal sympathetic paraganglia in thorax, abdomen and pelvis (15~20%) or parasympathetic paraganglia in the head and neck region (~1%), respectively. Functional imaging, such as 123I-Meta-Iodobenzylguanidine (MIBG) scintigraphy with single photon emission computed tomography with a CT (SPECT/CT), offers high specificity for PPGL but necessitates 24-hour delayed imaging, pre-processing thyroid protection with a potassium iodide solution, and medication reconciliation to prevent the inhibition of 123I-MIBG uptake. Conversely, 18F-L-dihydroxyphenylalanine (FDOPA), a radiopharmaceutical for positron emission tomography (PET) imaging, is specifically absorbed and accumulated by chromaffin cells, offering better image quality and convenience compared to 123I-MIBG scintigraphy. 18F-FDOPA PET/CT has been approved for the localization, staging, and detection of PPGL recurrences in European and other countries. Therefore, the aim of this study was to compare prospectively the diagnostic performances of 18F-FDOPA PET/CT and 123I-MIBG scintigraphy with SPECT/CT in patients with PPGL.

Detailed Description

Not provided

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pheochromocytoma / paraganglioma			Diagnostic Test: F-18 FDOPA PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
F-18 FDOPA PET/CT	Diagnostic Test	Nuclear medicine imaging modalities	Pheochromocytoma / paraganglioma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-inferiority in diagnostic sensitivity of F-18 FDOPA PET/CT compared with that of I-123 MIBG SPECT/CT		Time interval of two imaging modalities was in the range of 1-15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspected PPGL based on a biochemical screening, including 24-hour urinary total normetanephrine, metanephrine, norepinephrine, and epinephrine, along with plasma free concentrations of normetanephrine and metanephrine conducted within the past 6 months
an adrenal incidentaloma, suggestive of PPGL on anatomical imaging (CT or MRI) performed within the past 6 months
characteristic symptoms and signs of PPGL
suspected of recurrence or metastases of known PPGL.

Exclusion Criteria:

pregnant and lactating women
individuals aged less than 15 years
patients with a serum creatinine level greater than 3 mg/dL due to chronic renal failure
patients with a second primary cancer that was not in complete remission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients suspected of having PPGL or those showing recurrence and/or distant metastasis of PPGL were enrolled

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul	Songpa-gu	05505	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 27, 2023
Reset	Jun 21, 2024

Submission Tracking

Estimated Results First Submitted Date

Dec 27, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 27, 2023			Jun 21, 2024

Condition Browse Module

MeSH Terms

ID	Term
D010673	Pheochromocytoma
D010235	Paraganglioma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

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Browse Branches

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