Clinical trial · Interventional
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
NCT06122610CI-TRIAL-00115551completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer. Participants will: * Complete two phases involving 6 visits * Undergo additional research PET/CT, and possibly SPECT/CT scans
Conditions
Conditions (2)
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 |
| Somatostatin Receptor-positive Neuroendocrine Tumor | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-Dotatate | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
| 64Cu-Dotatate | Drug | — | UNRESOLVED |
| Photon Emission Tomography / CT (PET/CT) | Device | — | UNRESOLVED |
| Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants treated with Lutathera
- interventionNames
- Device: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
- Device: Photon Emission Tomography / CT (PET/CT)
- Drug: 64Cu-Dotatate
- Drug: 177Lu-Dotatate
Primary outcomes (1)
- measure
- Compare pre-therapy and post-therapy voxel-based dosimetry estimates
- timeFrame
- Baseline and 120 hours post-dose
- description
- Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor Exclusion Criteria: * Unable to lie flat during or tolerate PET/CT or SPECT/CT * Known incompatibility to CT. SPECT, or PET scans * Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.