Neuroendocrine TumorsPhase 2NCT05255159
Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
A Phase 2 study testing 18F-DOPA with furosemide in people with Neuroendocrine Tumors, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 18F-DOPA with furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2022to 31 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 18F-DOPA with furosemide
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DOPA with furosemideDiagnostic test
Diagnostic 18F-DOPA PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| 18F-DOPA PET/CT scan | Experimental | 4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan Receives: Diagnostic Test: 18F-DOPA with furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
Secondary outcomes (3)
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
Measured: Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
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
Measured: 12 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans
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
Measured: 18 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start15 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Abele, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255159
- Sponsor's protocol ID
- HREBA.CC-21-0353
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No