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Radioisotope Therapy

Lutetium-177 Therapy for Neuroendocrine Tumors (LUMOD-ID Trial)

Phase 2

Recruiting

Led By Stephen Graves, Ph.D., DABR

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

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

Must have

Aged ≥ 18 years at time of consent

Pathologically confirmed malignant neoplasm that is a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with known or believed gastroenteropancreatic origin

Must not have

Uncontrolled intercurrent illness including ongoing or active infection, fever, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Prior peptide-receptor radiotherapy (PRRT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if personalized dosing of Lutetium-177 DOTATATE can improve treatment outcomes for adults with unresectable neuroendocrine tumors. Participants will undergo imaging scans,

Who is the study for?

This trial is for adults with neuroendocrine tumors that can't be removed by surgery. Participants will need to undergo special PET imaging scans and are willing to follow up regularly at the clinic. Specific eligibility details aren't provided, but typically include factors like age, health status, and type of tumor.

What is being tested?

The study tests if customizing doses of Lutathera based on individual dosimetry leads to better outcomes compared to standard FDA-approved treatment. Patients will either receive the standard dose or a personalized dose determined by advanced imaging techniques.

What are the potential side effects?

While specific side effects are not listed here, Lutathera may commonly cause nausea, vomiting, fatigue, and low blood counts which could lead to an increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer is a type of slow-growing tumor from the digestive system.

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My disease is visible and active on specific scans.

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I am fully active or able to carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have previously undergone peptide-receptor radiotherapy.

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I don't have another cancer that would interfere with this study's treatment.

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My kidneys have been exposed to more than 10 Gy of radiation.

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I've had radiation that affected 25% of my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) at 6 months after treatment

Secondary study objectives

Correlation of hematologic toxicities

Time to disease progression

Treatment emergent toxicity assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dosimetry-based lutetium Lu 177 dotatate therapyExperimental Treatment1 Intervention

Intravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Intended administered radioactivity: Cycle 1: 200 millicuries (mCi) Cycles 2, 3, and 4: based upon dosimetry for radiation exposure to bone marrow (no more than 1 Gy per administration) and kidneys (maximum dose 28 Gy total). Not to exceed 400 millicuries (mCi) per cycle (1400 mCi maximum for all cycles).

Group II: Standard lutetium Lu 177 dotatateActive Control1 Intervention

Intravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Each cycle is intended to receive 200 millicuries of radioactivity for a total treatment of 800 millicuries.

0 / 9Eligibility criteria met