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Radiopharmaceutical

Lutathera for Neuroendocrine Tumors

Phase 2

Waitlist Available

Research Sponsored by Advanced Accelerator Applications

Eligibility Criteria Checklist

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

Must have

Expression of somatostatin receptors confirmed by a somatostatin receptor imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake observed in the target lesions more or equal to the normal liver uptake.

Patients from 12 to < 18 years of age at the time of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after the last lutetium [lu 177] dotatate dose

Awards & highlights

Study Summary

This trial is testing a new cancer drug, Lutathera, on patients aged 12-18 with either GEP-NETs or PPGLs. The safety and dosage of the drug will be evaluated.

Who is the study for?

Adolescents aged 12 to <18 with advanced or metastatic GEP-NETs or PPGLs that can't be surgically removed. They must have somatostatin receptor-positive tumors, a Karnofsky score >=50 or Lansky Play-Performance Scale score >=50, and parental consent. Excluded are pregnant/breastfeeding teens, those with certain medical conditions, uncontrolled diseases, inadequate lab values, not using contraception (if applicable), known drug allergies, and other malignancies.Check my eligibility

What is being tested?

The trial is testing the safety and dosimetry of Lutathera in young patients with specific neuroendocrine tumors. It's an open-label study where all participants receive the same treatment without a comparison group. At least eight will be enrolled for GEP-NETs and as many as possible for PPGLs to assess how well they tolerate the drug and how it distributes in their bodies.See study design

What are the potential side effects?

Possible side effects of Lutathera include nausea, vomiting, fatigue, low blood counts leading to increased infection risk or bleeding problems. Kidney damage and liver toxicity may also occur. Some might experience allergic reactions to the medication.

Eligibility Criteria

Inclusion Criteria

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

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My tests show my tumor has somatostatin receptors, similar to or more than my liver.

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I am between 12 and 17 years old.

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I am mostly self-sufficient and can do most of my daily activities.

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My PPGL cancer has spread or can't be removed by surgery.

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My GEP-NET is advanced, cannot be surgically removed, and is well-differentiated with a Ki-67 index of 20% or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after the last lutetium [lu 177] dotatate dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after the last lutetium [lu 177] dotatate dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after the last lutetium [lu 177] dotatate 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

Absorbed radiation doses in target organ

Incidence of adverse events (AEs) after the 1st treatment cycle

Secondary outcome measures

Area Under plasma concentration-time Curve from time 0 to 72 hours (AUC0-72) of Lutetium [Lu 177] dotatate in adolescents and adults

Comparative assessment of organ absorbed doses in adolescents and adults

Incidence of adverse events (AEs) during the long term follow-up

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: GEP-NET and PPGLExperimental Treatment1 Intervention

All eligible participants will receive Lutathera (7.4 GBq/200 mCi x 4 administrations every 8 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Advanced Accelerator ApplicationsLead Sponsor

35 Previous Clinical Trials

2,936 Total Patients Enrolled

9 Trials studying Neuroendocrine Tumors

1,715 Patients Enrolled for Neuroendocrine Tumors

Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals

2,153 Previous Clinical Trials

4,011,308 Total Patients Enrolled

26 Trials studying Neuroendocrine Tumors

3,118 Patients Enrolled for Neuroendocrine Tumors

Media Library

Lutetium [177Lu] oxodotreotide/dotatate (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04711135 — Phase 2

Neuroendocrine Tumors Research Study Groups: GEP-NET and PPGL

Neuroendocrine Tumors Clinical Trial 2023: Lutetium [177Lu] oxodotreotide/dotatate Highlights & Side Effects. Trial Name: NCT04711135 — Phase 2

Lutetium [177Lu] oxodotreotide/dotatate (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04711135 — Phase 2

Frequently Asked Questions

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

How many participants are being monitored as part of this research?

"To conduct the trial, 8 patients that fulfil the eligibility requirements must be enrolled. Advanced Accelerator Applications is managing this research from medical centres in Cincinnati Children's Hospital and Children's Hospital of Philadelphia respectively."

Answered by AI

Are any fresh participants being accepted into this clinical trial?

"Affirmative. The information posted on clinicaltrials.gov indicates that this experimental medical study, which was first published on August 31st 2022, is still recruiting participants. This trial intends to enroll 8 individuals from 6 different healthcare centres."

Answered by AI

To what extent are hospitals involved in the implementation of this trial?

"This medical research is being conducted in 6 distinct sites, 3 of which are Cincinnati, Philadelphia and Houston. To reduce the burden associated with travel, it's best to enroll at a clinic near you if possible."

Answered by AI

Does this research program accept participants of advanced age?

"This research trial is open to adolescents aged 12-17."

Answered by AI

Has the FDA authorized Lutetium [177Lu] oxodotreotide/dotatate for usage?

"Our internal evaluation yielded a score of 2 for the safety of Lutetium [177Lu] oxodotreotide/dotatate, due to there being no evidence supporting efficacy but some data indicating its safety."

Answered by AI

Who is eligible for participation in this experiment?

"Eligibility for this trial is restricted to those with paraganglioma who are aged between 12 and 17. Currently, the researchers need 8 participants."

Answered by AI

What key goals are researchers hoping to achieve through this medical experiment?

"According to the clinical trial sponsor, Advanced Accelerator Applications, this experiment is primarily focused on monitoring adverse events that occur within 8 days of administering Lutetium [Lu 177] dotatate. Secondary objectives include analyzing Tmax, organ absorbed doses and volume distribution in adolescents versus adults. Blood samples are being collected for pharmacokinetic characterisation to assess these outcomes accurately."

Answered by AI

What prior research has been completed using Lutetium [177Lu] oxodotreotide/dotatate?

"In 2014, the Cross Cancer Institute began researching lutetium [177Lu] oxodotreotide/dotatate and has since completed 5 trials. Currently, 35 clinical studies are actively recruiting with a majority of these occuring in Cincinnati, Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

2022. "Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04711135.

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