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Radiopharmaceutical

Novel Imaging Techniques for Neuroendocrine Tumors

Phase 1

Waitlist Available

Led By Steve Cho, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose

Awards & highlights

Study Summary

This trial seeks to find out if PET/CT scans can improve safety of a cancer treatment for neuroendocrine tumors. Participants will have 6 visits for scans.

Who is the study for?

This trial is for people with neuroendocrine tumors who are candidates for a treatment called Lutathera. Participants should be able to lie flat and tolerate PET/CT or SPECT/CT scans without known incompatibilities, and must be likely to follow study procedures.Check my eligibility

What is being tested?

The study tests if DetectnetTM PET/CT can make Lutathera therapy safer. It involves two phases with six visits where participants undergo additional research PET/CT, and possibly SPECT/CT scans.See study design

What are the potential side effects?

Potential side effects may include discomfort from lying still during scans, reactions to contrast agents used in imaging (like itching or rash), radiation exposure risks, and anxiety from being in enclosed spaces during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a candidate for a specific treatment targeting my neuroendocrine tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 96 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare pre-therapy and post-therapy voxel-based dosimetry estimates

Secondary outcome measures

Absorbed radiation doses

Absorbed radiation doses of 64Cu-DOTATATE

Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants treated with LutatheraExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)

2020

N/A

~20

177Lu-Dotatate

2020

Completed Phase 2

~40

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,186 Previous Clinical Trials

3,169,437 Total Patients Enrolled

4 Trials studying Neuroendocrine Tumors

55 Patients Enrolled for Neuroendocrine Tumors

Steve Cho, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

4 Previous Clinical Trials

29 Total Patients Enrolled

Frequently Asked Questions

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

Has the use of Lutathera been officially endorsed by the FDA?

"The safety of patients receiving Lutathera is calculated to be a 1 due to the limited data available from this Phase 1 trial. Thus far, efficacy and safety have not been fully established."

Answered by AI

Are there any available vacancies to participate in this research project?

"Unfortunately, the clinicaltrial.gov data reveals that this medical research initiative is not presently recruiting participants. The study was first posted on November 1st 2023 and edited for the last time two days later; however, there are currently 2,695 other trials open to recruitment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

2024. "Using Novel Imaging to More Safely Treat Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06122610.

All > Neuroendocrine Tumor