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Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors

NCT03044977 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-16

No results posted yet for this study

Summary

This study is designed to identify the best tolerated doses of \[131\]Iodine-MIBG and \[90\]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the safest and best tolerated doses of these drugs (when combined together) is unknown.

Conditions

  • Neuroendocrine Tumor, Malignant
  • Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting

Interventions

DRUG

90Y-DOTA-3-Tyr-Octreotide

Peptide receptor radiotherapy (PRRT) using Yttrium-90 as the active radionuclide. For intravenous administration only.

DRUG

131I-MIBG

Peptide receptor radiotherapy (PRRT) using Iodine-131 as the active radionuclide. For intravenous administration only.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • David Bushnell

    lead OTHER

Principal Investigators

  • David Bushnell, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-07
Primary Completion
2025-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044977 on ClinicalTrials.gov