Alpha-radiation Imaging for Neuroendocrine Tumors

KG
YM
Overseen ByYusuf Menda, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging method can detect neuroendocrine tumors, which are rare growths often originating in the digestive tract or lungs. The imaging employs a special substance called \[203Pb\]VMT-α-NET (an experimental imaging agent) to enhance tumor visibility, paving the way for a similar treatment to combat these tumors with radiation. It suits adults with a well-defined neuroendocrine tumor who have already undergone a scan showing the tumor has somatostatin receptors (specific proteins on the tumor surface). As an Early Phase 1 trial, this research focuses on understanding how the imaging agent functions in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial requires a 24-hour discontinuation of somatostatin analogue therapy, unless your doctor thinks it's unsafe for you. If you're on long-acting somatostatin analogue treatment, it must be stopped at least 20 days before the first day of the study.

What prior data suggests that [203Pb]VMT-α-NET is safe for imaging neuroendocrine tumors?

Previous studies found that [203Pb]VMT-α-NET did not cause any serious side effects. Patients using this imaging agent experienced no severe adverse effects, suggesting it is generally well-tolerated. The imaging agent aims to detect neuroendocrine tumors using a special scan called SPECT/CT. Although this study is still in the early stages of human testing, the absence of severe side effects so far is a positive sign for safety.12345

Why are researchers excited about this trial?

Unlike traditional treatments for neuroendocrine tumors, which often involve surgery, chemotherapy, or targeted therapy, [203Pb]VMT-α-NET introduces a novel approach by using alpha-radiation imaging. This treatment utilizes a radioactive compound, [203Pb], that targets tumor cells directly, potentially allowing for more precise imaging and better dosimetry. Researchers are excited because this method not only helps in pinpointing tumor locations with high accuracy but also minimizes damage to surrounding healthy tissue. This could lead to improved outcomes and fewer side effects compared to conventional treatments.

What evidence suggests that [203Pb]VMT-α-NET is effective for identifying neuroendocrine tumors?

Research has shown that [203Pb]VMT-α-NET, a new imaging agent, could help detect neuroendocrine tumors. In early studies, its similar agent, [212Pb]VMT-α-NET, effectively slowed tumor growth and even completely eliminated some tumors. In this trial, participants will receive [203Pb]VMT-α-NET for imaging. It has been used in patients without causing serious side effects, suggesting it might be safe. The aim is to use this imaging to plan targeted treatment with [212Pb]VMT-α-NET, potentially offering a new way to treat these tumors. Early results are promising, but more research is needed to fully understand its benefits.36789

Who Is on the Research Team?

YM

Yusuf Menda, M.D.

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take care of myself and perform daily activities.
I have a tumor positive for somatostatin receptors, confirmed by a PET/CT scan within the last year.
My tumor is a Grade 1 or 2 neuroendocrine tumor, originating from the midgut or foregut.
See 4 more

Exclusion Criteria

Individuals who are pregnant or breast feeding. A pregnancy test will be administered to individuals of child-bearing potential (per institutional policies) at screening. Individuals must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.
Individuals of reproductive potential who decline to use effective contraception through the study (22 days equaling 10 half-lives).
I haven't taken any experimental drugs in the last 4 weeks.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging and Dosimetry

Participants receive a microdose of [203Pb]VMT-α-NET followed by serialized imaging and dosimetry measurements over 4 days

4 days
Daily imaging visits

Follow-up

Participants are monitored for safety and effectiveness after imaging

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • [203Pb]VMT-α-NET
Trial Overview [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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: [203Pb]VMT-α-NET SPECT/CTExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yusuf Menda

Lead Sponsor

Trials
3
Recruited
70+

Viewpoint Molecular Targeting

Industry Sponsor

Trials
4
Recruited
570+

Holden Comprehensive Cancer Center

Collaborator

Trials
27
Recruited
710+

Perspective Therapeutics

Industry Sponsor

Trials
6
Recruited
710+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Targeted alpha therapy (TAT) using lead-212 (212Pb) shows promise for treating neuroendocrine tumors (NETs), with the study identifying [212Pb]Pb-eSOMA-01 as a leading candidate based on its high tumor uptake and low kidney absorption in tests with tumor-bearing mice.
The ligands developed for this therapy demonstrated high radiochemical yields and stability, with [212Pb]Pb-eSOMA-01 achieving the highest absorbed dose in tumors (35.49 Gy/MBq) while minimizing exposure to healthy tissues, indicating a potential for safer and more effective treatment options.
[212Pb]Pb-eSOMA-01: A Promising Radioligand for Targeted Alpha Therapy of Neuroendocrine Tumors.Chapeau, D., Koustoulidou, S., Handula, M., et al.[2023]
Targeted alpha-particle therapy (TAT) using radiopharmaceuticals like 225Ac-DOTATATE and 213Bi-DOTATOC shows promise in treating metastatic gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs), with evidence of partial responses observed in the reviewed studies.
These therapies appear to have a favorable safety profile, as they did not show significant hematological, renal, or hepatotoxicity, suggesting they could be viable options after the failure of 177Lu-DOTATATE therapy.
Targeted alpha-particle therapy in neuroendocrine neoplasms: A systematic review.Koh, TT., Bezak, E., Chan, D., et al.[2022]
Neuroendocrine neoplasms (NEN), particularly well-differentiated types, can be effectively diagnosed and treated using peptide receptor radionuclide therapy (PRRT) with somatostatin receptor analogues, which have been shown to be a safe and effective treatment option following FDA and EMA approval of 177Lu-DOTATATE.
Current research is focused on enhancing the efficacy of PRRT and minimizing its toxicity through personalized treatment approaches, improved patient selection, and the development of new radiopharmaceuticals, indicating a promising future for NEN management.
Molecular imaging Theranostics of Neuroendocrine Tumors.Fortunati, E., Bonazzi, N., Zanoni, L., et al.[2023]

Citations

[203/212Pb]Pb-VMT-α-NET as a novel theranostic agent ...Preclinical evaluations have shown that [212Pb]Pb-VMT-α-NET therapies are effective in slowing tumor growth and resulted in complete durable ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36257061/
203 Pb-VMT-α-NET Scintigraphy of a Patient With ... - PubMedIn an end-stage midgut neuroendocrine tumor patient with carcinoid heart disease, right ventricular dysfunction, mildly reduced renal function, ...
Clinical Trials Using [203Pb]VMT-a-NET - NCINCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying [203pb]vmt-a-net.
(PDF) [Pb]Pb-VMT-α-NET as a novel theranostic agent for ...Results No high-grade adverse effects were observed in all patients evaluated with [²⁰³Pb]Pb-VMT-α-NET. All patients showed an initial high, but ...
A phase 0 first-in-human clinical trial of [203Pb]VMT-α-NET ...The goal of this work is to use 203Pb VMT-α-NET as the imaging agent to create a specialized patient treatment plan using 212Pb VMT-α-NET as a first-in-human ...
Study Details | NCT06479811 | [212Pb]VMT-Alpha-NET in ...Safety of [203Pb]VMT-alpha-NET (dose escalation cohort) and [212Pb]VMT-alpha-NET, Descriptive tabulations of toxicity will be provided, along with the agent ...
Interim safety and efficacy data of [ 212 Pb]VMT-α-NET in ...Conclusions: [212Pb]VMT-α-NET is safe up to 185 MBq (5 mCi) dose level, and the SMC supported dose escalate to cohort 3 at 277.5 MBq (7.5 mCi) ...
Alpha-Radiation Imaging Agent ([203Pb]VMT-alpha-NET) ...This early phase I trial tests the safety of [203 lead (Pb)] Viewpoint Molecular Targeting (VMT)-alpha-neuroendocrine tumor (NET) imaging agent.
NCT06427798 | Somatostatin-Receptors ( ...The nuclide 203Pb contained in [203Pb]VMT-alpha-NET emits gamma radiation suitable for single-photon emission computerized tomography (SPECT) imaging. These ...
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