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Alpha-radiation Imaging for Neuroendocrine Tumors

Phase < 1
Waitlist Available
Research Sponsored by Yusuf Menda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate performance status (ECOG of 0 or 1; or KPS of ≥70)
Aged ≥ 18 years at the time of study drug administration
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to [90Y]DOTA-tyr3-Octreotide, Octreoscan®, or [68Ga]Octreotide.
Lactating individuals who decline to withhold breastfeeding their child. As the effects of [203Pb]VMT-α-NET on the infant are unknown and relatively long half-life, women may not resume breast feeding for the current child.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study days 1 through 5
Awards & highlights
No Placebo-Only Group

Summary

This trial is to see if a new imaging technique can detect neuroendocrine tumors, which will help in treating them with alpha radiation therapy.

Who is the study for?
Adults over 18 with well-differentiated neuroendocrine tumors, confirmed by pathology, that are positive for somatostatin receptors and measurable on imaging. Participants must be able to consent, follow study procedures, have a good performance status, and not have severe illnesses or conditions affecting study compliance.
What is being tested?
[203Pb]VMT-α-NET is being tested to see if it can identify neuroendocrine tumors using SPECT/CT imaging. This trial is the preliminary step before testing alpha radiation therapy for these types of tumors.
What are the potential side effects?
As this is a first-in-human trial for [203Pb]VMT-α-NET, specific side effects are unknown but may include typical reactions to radiopharmaceutical agents such as nausea or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I am 18 years old or older.
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My tumor is a Grade 1 or 2 neuroendocrine tumor, originating from the midgut or foregut.
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I have a tumor that is at least 2 cm big, confirmed by CT or MRI.
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I do not have any severe illnesses that would stop me from following the study's requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to certain cancer imaging or treatment drugs.
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I am breastfeeding and cannot stop for the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study days 1 through 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and study days 1 through 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
Secondary study objectives
Measure radiation dose from [203Pb]VMT-α-NET dosimetrically
Single-time point survey

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: [203Pb]VMT-α-NET SPECT/CTExperimental Treatment2 Interventions
injection of \[203Pb\]VMT-α-NET with serialized imaging and dosimetry measurements
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPECT/CT
2014
N/A
~50

Find a Location

Who is running the clinical trial?

Viewpoint Molecular TargetingIndustry Sponsor
3 Previous Clinical Trials
551 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
280 Patients Enrolled for Neuroendocrine Tumors
Yusuf MendaLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
50 Patients Enrolled for Neuroendocrine Tumors
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
747 Total Patients Enrolled
5 Trials studying Neuroendocrine Tumors
97 Patients Enrolled for Neuroendocrine Tumors

Media Library

[203Pb]VMT-α-NET Clinical Trial Eligibility Overview. Trial Name: NCT05111509 — Phase < 1
Neuroendocrine Tumors Research Study Groups: [203Pb]VMT-α-NET SPECT/CT
Neuroendocrine Tumors Clinical Trial 2023: [203Pb]VMT-α-NET Highlights & Side Effects. Trial Name: NCT05111509 — Phase < 1
[203Pb]VMT-α-NET 2023 Treatment Timeline for Medical Study. Trial Name: NCT05111509 — Phase < 1
~5 spots leftby Sep 2025
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