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Radioactive Drug

Lutathera + Azedra for Gastrointestinal Cancer (SPORE-3 Trial)

Phase 1 & 2
Recruiting
Led By David Bushnell, M.D.
Research Sponsored by David Bushnell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be:
Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-treatment
Awards & highlights

SPORE-3 Trial Summary

This trial is testing the best tolerated doses of two different radioactive drugs, Lutathera and Azedra, when given together to treat neuroendocrine tumors in the middle part of the gut.

Who is the study for?
Adults aged 18-80 with midgut neuroendocrine tumors, including well-differentiated tumors, pheochromocytoma or paraganglioma. Participants must agree to lifestyle considerations and contraception use, have a tumor ≥1.5 cm in diameter on imaging scans, and an adequate performance status. Exclusions include pregnancy, severe heart failure, recent cancer treatments or surgeries within the last 4 weeks.Check my eligibility
What is being tested?
The trial is testing the safety of combining two radioactive drugs: Lutathera(R) and Azedra(R), which are usually not given together but are individually approved for treating midgut neuroendocrine tumors. The goal is to find out the safest doses when these drugs are combined.See study design
What are the potential side effects?
Potential side effects may include reactions related to radiation exposure such as nausea, fatigue, kidney damage or blood cell count changes since both Lutathera and Azedra are radioactive therapies designed to target tumor cells.

SPORE-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has been confirmed by lab tests.
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My disease is at least 1.5 cm big as shown on a scan.
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My tumor is a low or intermediate grade neuroendocrine tumor, likely started in the midgut.
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I am mostly active and can care for myself.
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I have been diagnosed with pheochromocytoma.
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My doctor has recommended LUTATHERA® or AZEDRA® for my treatment.
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I am between 18 and 80 years old.
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I have been diagnosed with paraganglioma.

SPORE-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Determination of maximum tolerated radiation dose (MTD) to the bone marrow.
Phase 1: Determination of maximum tolerated radiation dose (MTD) to the kidneys
Phase 2: Objective Response Rate (ORR)
Secondary outcome measures
Number of Treatment-Related Adverse Events
Tumor size

SPORE-3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Combination TherapyExperimental Treatment2 Interventions
Combined treatment with Lutathera® and Azedra® Administered amounts of each drug are based on imaging and radiation dose constraints to the kidneys and the bone marrow. The drug administration is individualized to each participant.
Group II: Lutathera® onlyActive Control1 Intervention
Single agent Lutathera® administered per standard of care: 200 millicuries of drug every 8 weeks for a total of 4 doses.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,908 Total Patients Enrolled
7 Trials studying Neuroendocrine Tumors
152 Patients Enrolled for Neuroendocrine Tumors
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,301 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,573 Patients Enrolled for Neuroendocrine Tumors
Progenics Pharmaceuticals, Inc.Industry Sponsor
33 Previous Clinical Trials
4,900 Total Patients Enrolled

Media Library

Azedra (Radioactive Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04614766 — Phase 1 & 2
Neuroendocrine Tumors Research Study Groups: Combination Therapy, Lutathera® only
Neuroendocrine Tumors Clinical Trial 2023: Azedra Highlights & Side Effects. Trial Name: NCT04614766 — Phase 1 & 2
Azedra (Radioactive Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614766 — Phase 1 & 2

Frequently Asked Questions

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

Are there still opportunities to become involved in this clinical trial?

"This clinical trial is currently not accepting patient applications. It was initially posted on the 12th of December in 2023 and most recently updated on the 7th of July 2022. However, for those still seeking a medically-related study, 2483 trials are actively recruiting patients with neuroendocrine tumors and 27 studies require volunteers for Azedra research."

Answered by AI

What has been the primary objective of Azedra's application?

"Azedra is the most common treatment for paraganglioma, as well as neoplasm metastasis, primary neuroblastomas and irresectable, iobenguane-scan positive pheochromocytomas."

Answered by AI

Who is the ideal demographic for involvement in this clinical study?

"This medical trial has strict eligibility criteria, seeking patients aged between 18 and 80 who have been diagnosed with neuroendocrine tumors. Roughly 50 individuals are being recruited for the study."

Answered by AI

How many individuals are taking part in this experiment?

"This study is currently not enrolling patients, having been initially posted on December 1st 2023 and last updated July 7th 2022. Alternatives are available with 2483 medical trials that accept participants suffering from neuroendocrine tumours and 27 studies for Azedra still recruiting."

Answered by AI

Is this investigation open to individuals over the age of 45?

"This clinical trial is seeking subjects with an age bracket of 18 to 80 years old."

Answered by AI
Recent research and studies
~26 spots leftby Oct 2025