Trial · NCT05359146
Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3)
NCT05359146, Early phase 1, Unknown, University Hospital, Basel, Switzerland
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3). Trials, record NCT05359146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05359146
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3)
- NCT number
- NCT05359146
- Status
- Unknown
- Phases
- Early phase 1
- Enrollment
- 16 participants, estimated
- Lead sponsor
- University Hospital, Basel, Switzerland
- Conditions
- Neuroendocrine Neoplasia's (NENs), Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
- Interventions
- 161Tb-DOTA-LM3, 177Lu-DOTATOC
- First posted
- 2022-05-03
- Last updated
- 2024-04-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in bone marrow doses after sequential injection of a non-therapeutic test activity of 161Tb-DOTA-LM3 and 177Lu-DOTATOC in the same patients. | ~ 3, ~ 24, ~ 72 and ~ 168 hours post injection | Assessment and comparison of the tumour-to-bone marrow dose ratio of 161Tb-DOTA-LM3 vs 177Lu-DOTATOC. In order to get kinetic information of 161Tb-DOTA-LM3 and 177Lu-DOTATOC for this task total body scintigraphy and SPECT/CT of abdomen are performed at different time points post injection 161Tb-DOTA-LM3 or 177Lu-DOTATOC: \~ 3, \~ 24, \~ 72 and \~ 168 hours. |
| Primary | Change in kidney doses after sequential injection of a non-therapeutic test activity of 161Tb-DOTA-LM3 and 177Lu-DOTATOC in the same patients. | ~ 3, ~ 24, ~ 72 and ~ 168 hours post injection | Assessment and comparison of the tumour-to-kidney dose ratio of 161Tb-DOTA-LM3 vs 177Lu-DOTATOC. In order to get kinetic information of 161Tb-DOTA-LM3 and 177Lu-DOTATOC for this task total body scintigraphy and SPECT/CT of abdomen are performed at different time points post injection 161Tb-DOTA-LM3 or 177Lu-DOTATOC: \~ 3, \~ 24, \~ 72 and \~ 168 hours. |
| Secondary | Change in median tumour dose per gigabequerel (GBq) injected activity | ~ 3, ~ 24, ~ 72 and ~ 168 hours post injection | Assessment of the median tumour dose per GBq injected activity (Median of the mean of 2 - 6 tumours per patient which can be identified with both compounds.). Kinetic information of the biodistribution of 161Tb-DOTA-LM3 and 177Lu-DOTATOC for dosimetry calculations will be generated by performing sequential SPECT/CT scans for example at \~ 3, \~ 24, \~ 72 and \~ 168 hours. |
| Secondary | Change in median tumour-to-bone marrow- dose ratio | ~ 3, ~ 24, ~ 72 and ~ 168 hours post injection | Kinetic information of the biodistribution of 161Tb-DOTA-LM3 and 177Lu-DOTATOC for dosimetry calculations will be generated by performing sequential SPECT/CT scans for example at \~ 3, \~ 24, \~ 72 and \~ 168 hours. |
| Secondary | Change in median tumour-to-kidney- dose ratio | ~ 3, ~ 24, ~ 72 and ~ 168 hours post injection | Kinetic information of the biodistribution of 161Tb-DOTA-LM3 and 177Lu-DOTATOC for dosimetry calculations will be generated by performing sequential SPECT/CT scans for example at \~ 3, \~ 24, \~ 72 and \~ 168 hours. |
| Secondary | Bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | ~ 3, ~ 24, ~ 72 and ~ 168 hours post injection | Assessment of bone marrow toxicity after test injection of 177Lu-DOTATOC and 161Tb-DOTA-LM3 using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Change in median dose per GBq injected activity in other organs than bone marrow and kidneys | ~ 3, ~ 24, ~ 72 and ~ 168 hours post injection | Assessment of the median dose per GBq injected activity in other organs than bone marrow and kidneys. Kinetic information of the biodistribution of 161Tb-DOTA-LM3 and 177Lu-DOTATOC for dosimetry calculations will be generated by performing sequential SPECT/CT scans for example at \~ 3, \~ 24, \~ 72 and \~ 168 hours. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05359146
GET https://conductscience.org/api/trials/v1/NCT05359146/registered