Trial · NCT06121271
Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications
NCT06121271, Phase 2, Not yet recruiting, University College, London
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications. Trials, record NCT06121271. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06121271
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications
- NCT number
- NCT06121271
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 110 participants, estimated
- Lead sponsor
- University College, London
- Conditions
- Bronchial and Thymic Neuroendocrine Tumour, Paraganglioma/ Phaeochromocytoma, Medullary Thyroid Carcinoma, Those Requiring Repeat Peptide Receptor Radionuclide Therapy
- Interventions
- Lu-177 DOTATATE (Lutathera®)
- First posted
- 2023-11-07
- Last updated
- 2023-12-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To prospectively evaluate safety in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications | 4 years | Treatment-related toxicity will be assessed in all participants by Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0. This will be done by performing electrocardiograms (ECGs), vital signs, and clinical laboratory tests (haematology, clinical chemistry, or urinalysis)at the baseline and before and after every treatment and during the follow-up period. |
| Primary | To prospectively evaluate tolerability in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications | 4 years | Treatment-related side effects and cancer-related symptoms will be assessed in all participants Questionnaire after every treatment and during the follow-up period. |
| Primary | To prospectively evaluate efficacy in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor expressing neuroendocrine tumours (NET) in currently unlicensed indications | 4 years | The efficacy of Lu-177 DOTATATE is assessed in all participants by measuring Progression Free Survival (PFS) and defined as the time from the date of start of treatment the date of the first documented tumour progression or death due to any cause. |
| Secondary | • To determine the Objective Response Rate (ORR) | 2 years | ORR is defined by evaluating post-therapy scans (using RECIST Criteria, Version 1.1) looking for the percentage of patients who had a partial response or complete response from the whole cohort over the treatment time of 2 years. |
| Secondary | • To determine the Overall Survival (OS). | 4 years | Overall Survival (OS) is defined as the time from the date of start of treatment till death or loss of contact or end of trial. |
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/NCT06121271
GET https://conductscience.org/api/trials/v1/NCT06121271/registered