Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors

Sponsor

University of Alberta (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05255159

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a single centre non-randomized non-blinded phase II prospective cohort study including 50 participants. The objective of this study is to directly compare 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG activity in patients with metastatic neuroendocrine tumors (NETs) on a lesion-by-lesion basis. The investigators will determine the prevalence of concordant versus discordant disease. Secondary objectives include assessing the standardized uptake value (SUV) and determining if there is any correlation between discordance and disease progression.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors	Diagnostic Test: 18F-DOPA with furosemide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 18F-DOPA PET/CT scan 4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan	Diagnostic Test: 18F-DOPA with furosemide Diagnostic 18F-DOPA PET/CT scan

Arm

Intervention/Treatment

Experimental: 18F-DOPA PET/CT scan

4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan

Diagnostic Test: 18F-DOPA with furosemide

Diagnostic 18F-DOPA PET/CT scan

Outcome Measures

Primary Outcome Measures

Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans [Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans]
Participants will be categorized as having concordant disease (all lesions 68Ga-HA-DOTATATE avid) or discordant disease (one or more lesions not 68Ga-HA-DOTATATE avid).

Secondary Outcome Measures

SUV of lesions on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans [Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans]
SUVmax of all lesions on all scans will be recorded and compared to SUVmean of the liver and blood pool
Assessment of disease progression - 12 months [12 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans]
All available clinical information will be reviewed 12 months after completion of the PET/CT scans with expert determination of treatment response, no treatment response, or disease progression
Assessment of disease progression - 18 months [18 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans]
All available clinical information will be reviewed at 18 months after completion of the PET/CT scans with expert determination of treatment response, no treatment response, or disease progression

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

History of biopsy proven neuroendocrine tumor including (but not limited to): gastrointestinal NET, pancreatic NET, pulmonary NET, NET unknown primary, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
At least two abnormal 68Ga-HA-DOTATATE positive lesions suspected to represent neuroendocrine tumor (at least tow lesions with SUVmax > SUV meanliver).
Age greater or equal to 40
Ability to provide written informed consent prior to participation in the study

Exclusion Criteria:

Weight > 225 kg (weight limitation of PET/CT scanner)
Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
Any medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
Previous allergic reaction to 18F-DOPA
Lack of intravenous access
Pregnant
Breastfeeding
Less than 40 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

University of Alberta

Investigators

Principal Investigator: Jonathan Abele, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alberta

ClinicalTrials.gov Identifier:

NCT05255159

Other Study ID Numbers:

HREBA.CC-21-0353

First Posted:

Feb 24, 2022

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuroendocrine Tumors

Furosemide

Study Results

No Results Posted as of May 24, 2022