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Radioisotope Therapy

90Y-DOTA-tyr3-Octreotide for Neuroendocrine Tumors

Phase 2
Waitlist Available
Led By M. Sue O'Dorisio, MD, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that involves using a radioactive substance to target and kill cancer cells.

Eligible Conditions
  • Neuroendocrine Tumors
  • Meningioma
  • Medulloblastoma
  • Neuroblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Tumor Response at 9 Months After Last Treatment
Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events
Percentage of Patients With Grade 4 or Higher Renal Adverse Event.
Secondary outcome measures
Accuracy of 68Ga-DOTATOC PET/CT in Participants
Response to therapy of lesions identified by 68Ga-DOTATOC PET/CT
Positron-Emission Tomography

Trial Design

1Treatment groups
Experimental Treatment
Group I: 90Y-DOTA-tyr3-OctreotideExperimental Treatment3 Interventions
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan
2017
Completed Phase 2
~40
Lysine
FDA approved
90Y-DOTA tyr3-Octreotide
2017
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
446 Previous Clinical Trials
879,463 Total Patients Enrolled
3 Trials studying Neuroendocrine Tumors
3,132 Patients Enrolled for Neuroendocrine Tumors
National Institutes of Health (NIH)NIH
2,694 Previous Clinical Trials
6,952,466 Total Patients Enrolled
7 Trials studying Neuroendocrine Tumors
163 Patients Enrolled for Neuroendocrine Tumors
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,284 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,584 Patients Enrolled for Neuroendocrine Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualifications to take part in this test?

"The ideal candidate for this medical trial would be suffering from neuroblastoma and between 6 months to 9 years old. Around 46 patients are needed for the study."

Answered by AI

How many volunteers are being sought for this experiment?

"This specific trial is not admitting patients at the moment. However, it was first posted on September 29th, 2017 and edited as recently as October 6th, 2022. If you're interested in other trials, there are presently 426 trials actively admitting patients with neuroblastoma and 29 trials for 90Y-DOTA-tyr3-Octreotide actively searching for participants."

Answered by AI

Does this research project require participants to be of a certain age?

"The age range for patients that this trial is recruiting are those who are older than 6 months and below 90 years old."

Answered by AI

What conditions does 90Y-DOTA-tyr3-Octreotide commonly help ameliorate?

"When oral administration is not an option, 90Y-DOTA-tyr3-Octreotide can be used as a treatment for panhypopituitarism and pituitary dwarfism."

Answered by AI

Has there been any research like this before?

"Since 2007, 90Y-DOTA-tyr3-Octreotide has been under investigation in 29 clinical trials. These international studies, which are hosted in 62 cities across 14 countries, were launched after the drug's Phase 4 approval in 2007. The first study was sponsored by Baxter Healthcare Corporation and included 4640 participants."

Answered by AI

Has this medication been cleared by the FDA?

"While there is some evidence from Phase 2 clinical trials to support the safety of 90Y-DOTA-tyr3-Octreotide, this medication has not yet been proven effective."

Answered by AI

Are there any available slots for volunteers in this research project?

"This particular clinical trial is no longer recruiting patients. The original posting date was September 29th, 2017 and the last edit was on October 6th, 2022. If you are looking for other trials, 426 studies related to neuroblastoma are currently admitting patients and 29 trials concerning 90Y-DOTA-tyr3-Octreotide are also seeking participants."

Answered by AI

Are there other scientific papers that mention 90Y-DOTA-tyr3-Octreotide?

"At the moment, 29 studies are underway that involve 90Y-DOTA-tyr3-Octreotide. Of these active trials, 6 have progressed to Phase 3 testing. Most of the research being conducted on 90Y-DOTA-tyr3-Octreotide is happening in Los Angeles but there are a total of 105 clinical trial sites across the United States."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
Sue O'Dorisio 2017. "Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03273712.
~5 spots leftby Apr 2025
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