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Radioisotope Therapy

Lutathera for Neuroendocrine Tumors

Phase < 1

Waitlist Available

Led By Lisa Bodei, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Histologically proven or cytologically confirmed, non-resectable,GEP, bronchial or unknown primary NETs with liver-dominant disease with or without prior treatment with embolization

Subjects affected by histologically proven, somatostatin-receptor positive, progressive, nonresectable, liver-dominant metastatic GEP, bronchial or unknown primary tumors, G1, G2 and G3, according to the new WHO classification of 2017

Must not have

Deteriorated renal function: Serum creatinine >1.7 mg/dL OR EGFR <30 ml/min

Unmanageable urinary incontinence rendering the administration of 177Lu-DOTATATE unsafe

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether it's safe & effective to give Lutathera directly into the liver artery, compared to the standard approach of intravenous infusion in the arm.

Who is the study for?

This trial is for adults with certain types of neuroendocrine tumors that have spread to the liver and are not suitable for surgery. Participants must have a positive somatostatin-receptor, measurable disease progression, and be in relatively good health with an ECOG performance status of 0 or 1. They should agree to use contraception and can't join if they've had certain prior treatments like radiolabeled somatostatin analogs or extensive chemotherapy.

What is being tested?

The study tests Lutathera (177Lu-DOTATATE) delivered directly into the liver's artery versus standard intravenous infusion. It aims to determine which method is safer, more practical, and effective against cancer by comparing their effects on tumor growth.

What are the potential side effects?

Potential side effects may include nausea, vomiting, abdominal pain due to radiation exposure; fatigue; blood cell count changes leading to increased infection risk; kidney damage; and possible allergic reactions related to the drug components.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of NET that cannot be surgically removed and mainly affects my liver.

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My tumor is a type that grows in the digestive or respiratory system and cannot be surgically removed, but it responds to a specific hormone therapy.

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My tumor is a type that grows in the digestive or respiratory system and cannot be surgically removed, but it responds to a specific hormone therapy.

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

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My tumor is a certain type of neuroendocrine tumor, as classified by specific medical standards.

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My cancer has grown by at least 20%.

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My scan shows high levels of certain receptors in at least one cancer spot.

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I am experiencing symptoms due to my cancer.

Exclusion Criteria

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

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My kidney function is poor, with high creatinine or low filtration rate.

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I have severe urinary incontinence that makes certain cancer treatments unsafe.

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My liver is mostly affected by cancer, as confirmed by a radiologist.

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My side effects from previous treatments have not fully improved.

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I have had liver radioembolization treatment with 90Y-microspheres.

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My liver isn't working well (high INR, PTT, bilirubin or low albumin).

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My diabetes is not well-managed.

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

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My blood tests show low levels of hemoglobin, white cells, and platelets.

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My cancer is a type of aggressive neuroendocrine tumor.

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I have been treated with radiolabeled somatostatin analogs before.

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I am not pregnant or breastfeeding.

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I have had radiation therapy that affected more than a quarter of my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years 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

number of patients who successfully complete 2 IA injections

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRRT with 177Lu-DOTATATEExperimental Treatment1 Intervention

Patients will undergo a routine 68Ga-DOTATATE PET/CT. Patients with sufficient tumor uptake will be offered therapy with 177Lu-DOTATATE. The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

177Lu-DOTATATE

2010

Completed Phase 2

~150

0 / 21Eligibility criteria met