Clinical trial · Interventional
Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DOPA with furosemide | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DOPA PET/CT scan
- 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
- interventionNames
- Diagnostic Test: 18F-DOPA with furosemide
Primary outcomes (1)
- measure
- Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans
- timeFrame
- Within 1 year after completion of both 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).
Secondary outcomes (3)
- measure
- SUV of lesions on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available