Trial · NCT05668962
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
NCT05668962, Phase 2, Unknown, Massachusetts General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC. Trials, record NCT05668962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05668962
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
- NCT number
- NCT05668962
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Thyroid Cancer, Thyroid Carcinoma, Metastatic Thyroid Cancer, Follicular Thyroid Cancer, Unresectable Thyroid Gland Carcinoma, Papillary Thyroid Cancer
- Interventions
- Selpercatinib, Sodium Iodine I-131, rhTSH
- First posted
- 2022-12-30
- Last updated
- 2024-12-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 6 Months | RECIST v1.1 or Nies criteria in adolescents without RECIST-measurable disease The primary endpoint is best overall response (ORR) (CR and PR) at 6 months. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters |
| Secondary | Number of Participants with Treatment Related Adverse Events as Assessed CTCAE v5.0 | up to 2 years | The safety profile of selpercatinib plus I-131 treatment in this patient population, will be evaluated by assessing by the incidence of treatment-related adverse events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Secondary | Rate of restoration of I-131 uptake | Initial Treatment Day 28, Re- Treatment Day 28 up 7 months | The estimated rate of restoration of I-131 uptake in patients with RAI-refractory RET fusion-positive thyroid cancer treated with selpercatinib will be estimated by determining the rate of positive whole body scans performed after I-131 administration. |
| Secondary | thyroglobulin biochemical response rate | Initial Treatment Day 1, Day 21, 3 month follow up, 6 month follow up, Re- Treatment Day 1, follow up, up to 2 years | The estimated best thyroglobulin biochemical response rates will be determined by comparing serial serum thyroglobulin levels taken every 3 months following treatment to that of the pretreatment baseline level in participants with measurable serum thyroglobulin. Best biochemical response is defined as follows: equals normalization of thyroglobulin level; partial response equals ≥50% decrease from baseline thyroglobulin; stable disease equals \<50% decrease or increase from baseline; and biochemical progression equals ≥50% increase from baseline (each maintained for at least 4 weeks). |
| Secondary | Progression Free Survival | time from registration to the earlier of progression or death due to any cause up to 2 years | Kaplan-Meier Method |
| Secondary | Overall Survival | time from registration to death due to any cause or censored at date last known alive up to 2 years | Kaplan-Meier Method. |
| Secondary | Time to subsequent systemic treatment | 6 Months | Kaplan-Meier Method Time to subsequent systemic treatment in patients with RET fusion-positive RAIrefractory thyroid cancer will also be estimated. |
| Secondary | Overall Response Rate-Adolescent | 6 months | The structural, biochemical, and overall response rate perl \[19\] for adolescent patients who enroll without measurable disease will be reported descriptively for adolescents who enroll without RECIST measurable disease. |
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/NCT05668962
GET https://conductscience.org/api/trials/v1/NCT05668962/registered