Trial · NCT04903899
177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
NCT04903899, Phase 2, Recruiting, Jakob Stenman
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma. Trials, record NCT04903899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04903899
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
- NCT number
- NCT04903899
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Jakob Stenman
- Conditions
- Neuroblastoma Recurrent, Neuroblastoma
- Interventions
- 177Lu-DOTATATE
- First posted
- 2021-05-27
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response by the Revised International Neuroblastoma Response Criteria (INRC) at 1 month after the completion of therapy | 1 months following end of treatment | Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) |
| Secondary | Response based on 68Ga-DOTATOC PET/CT imaging at 1 and 4 months after completion of therapy in measurable target lesions | 1 and 4 months following end of treatment | Response based on 68Ga-DOTATOC PET/CT imaging after completion of therapy in measurable target lesions |
| Secondary | Response based on 123I-mIBG SPECT/CT imaging (when available) at 1 and 4 months after completion of therapy in measurable target lesions | 1 and 4 months following end of treatment | Response based on 123I-mIBG SPECT/CT imaging (when available) after completion of therapy in measurable target lesions |
| Secondary | Response by the Revised INRC criteria at 4 months after the completion of therapy | 4 months following end of treatment | Response by the Revised INRC criteria |
| Secondary | Progression-free survival | Time from registration to progression or death, up to 5 years following end of treatment | Time to progress or death, whichever occurs first |
| Secondary | Overall survival - up to 5 years after End of Treatment | Time from registration to the the date of death, up to 5 years following end of treatment | Overall survival |
| Secondary | Hematological and renal toxicity according to CTCAE 5.0 | From first treatment dose until the date of first documented progression, assessed up to 60 months | Hematological and renal toxicity according to CTCAE 5.0 |
| Other | Dosimetry (absorbed dose in Gy) in measurable target lesions and risk organs | At every administered dose of 177Lu-DOTATATE throughout the trial treatment phase (5 years) | Measured by SPECT/CT |
| Other | Semi-quantitative analysis of the expression of SSTR-2 on immunohistochemistry in the primary tumor histology | Throughout the trial treatment phase (5 years) | Semi-quantitative analysis of the expression of SSTR-2 on immunohistochemistry in the primary tumor histology |
| Other | The uptake on 68Gallium-DOTATOC PET/CT by SUVmax (maximum standardized uptake value) in measurable target lesions | At end of treatment, and 1 and 4 months after end of treatment. | Measured by SUVmax (maximum standardized uptake value) |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35359899 | DERIVED |
Source PubMed
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/NCT04903899
GET https://conductscience.org/api/trials/v1/NCT04903899/registered