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

Primary Purpose

Neuroendocrine Tumors

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
18F-DOPA with furosemide
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alberta HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DOPA PET/CT scan

Arm Description

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

Outcomes

Primary Outcome Measures

Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 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
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
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
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

Full Information

First Posted
January 31, 2022
Last Updated
November 16, 2022
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05255159
Brief Title
Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
Official Title
Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-DOPA PET/CT scan
Arm Type
Experimental
Arm Description
4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-DOPA with furosemide
Intervention Description
Diagnostic 18F-DOPA PET/CT scan
Primary Outcome Measure Information:
Title
Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans
Description
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).
Time Frame
Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
Secondary Outcome Measure Information:
Title
SUV of lesions on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans
Description
SUVmax of all lesions on all scans will be recorded and compared to SUVmean of the liver and blood pool
Time Frame
Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
Title
Assessment of disease progression - 12 months
Description
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
Time Frame
12 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans
Title
Assessment of disease progression - 18 months
Description
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
Time Frame
18 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Abele
Phone
780-407-6907
Email
jabele@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Abele
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Abele
Phone
780-407-6907
Email
jabele@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Jonathan Abele

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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