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Trial · NCT06395402

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

NCT06395402, Phase 2, Recruiting, University of Iowa

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry. Trials, record NCT06395402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06395402

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
NCT number
NCT06395402
Status
Recruiting
Phases
Phase 2
Enrollment
120 participants, estimated
Lead sponsor
University of Iowa
Conditions
Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2
Interventions
Lutetium Lu 177 dotatate therapy
First posted
2024-05-02
Last updated
2025-07-22

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryObjective Response Rate (ORR) at 6 months after treatment6 months after completion of treatment
Determine objective response rate in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) treated with dosimetrically-determined LUTATHERA administration compared to active control.
SecondaryTreatment emergent toxicity assessmentFrom treatment day 1 every 6 months for 5 years post-treatment
Determine treatment-emergent toxicity, as graded by the NCI's Common Terminology Criteria for Adverse Events (CTCAE) version 5 in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumor (GEPNET) treated with dosimetrically derived Lutathera compared to standard treatment. Endpoints are Incidence and severity of toxicities
SecondaryTime to disease progressionUp to 5 years post-treatmentDetermine time to progression in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumor (GEPNET) treated with dosimetrically derived Lutathera compared to standard treatment
SecondaryCorrelation of hematologic toxicitiesAt 6 months post-treatment
Assess correlation between hematologic toxicity and bone marrow dose in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumor (GEPNET) treated with dosimetrically derived LUTATHERA compared to active control

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.

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
34857617BACKGROUNDPubMed
34857621BACKGROUNDPubMed
35314056BACKGROUNDPubMed
35701215BACKGROUNDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT06395402

GET https://conductscience.org/api/trials/v1/NCT06395402/registered