Neuroendocrine Tumor Grade 2Early Phase 1NCT05111509
A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent
A Early Phase 1 study testing [203Pb]VMT-α-NET and SPECT/CT in people with Neuroendocrine Tumor Grade 2 and Neuroendocrine Tumor Grade 1, run by Yusuf Menda at 1 site in United States.
Trial summary
This is a first in man study to determine if [203Pb]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing [212Pb]-based alpha radiation therapy in neuroendocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor Grade 1
- What is being tested?
- [203Pb]VMT-α-NET and SPECT/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to provide informed consent
- Stated willingness to comply with all study procedures and availability for duration of study
- Aged ≥ 18 years at the time of study drug administration
- Pathologically confirmed (histology or cytology) well-differentiated neuroendocrine tumor (WHO Grade 1 or 2) with primary location known or believed to be midgut or foregut
- At least 1 somatostatin receptor positive tumor site as demonstrated by PET/CT study utilizing an FDA approved PET agent within 12 months of consent
- ≥1 evaluable site of disease measuring ≥ 2.0 cm in any dimension on CT or MRI
- Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
- Not experiencing an uncontrolled intercurrent illness such as: infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
Who cannot join
- 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).
- 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.
- Therapeutic investigational drug within 4 weeks of C1D1
- Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
- Subject's weight exceeds the limit of the imaging system.
- Long-acting somatostatin analogue treatment ≤ 20 days of C1D1
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to [90Y]DOTA-tyr3-Octreotide, Octreoscan®, or [68Ga]Octreotide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 0 First-in-human Clinical Trial of [203Pb]VMT-α-NET SPECT/CT for Somatostatin Receptor Imaging of Neuroendocrine Tumors
This is a first in man study to determine if [203Pb]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing [212Pb]-based alpha radiation therapy in neuroendocrine therapy.
Read the detailed description
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 therapy for treatment resistant or refractory neuroendocrine tumors of the foregut or midgut. The first step is to test the imaging agent [203Pb]VMT-α-NET. This requires a very small dose of the drug (microdose) which is then measured by a series of images (like CT scans) over 4 days. Blood samples are also drawn that that time. It is hoped the imaging will identify the tumors so that a therapy using [212Pb]VMT-α-NET can be created.
- Being tested
- [203Pb]VMT-α-NET, SPECT/CT
- Keywords
- Alpha Particles, Pb-203 radioisotope, Single Photon Emission Computed Tomography Computed Tomography, SPECT CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[203Pb]VMT-α-NETDrug
3 to 5 miliCuries of [203]Pb administered intravenously 60 minutes before the start of the scans.
SPECT/CTDevice
Scans are administered over 3 days: 1 hour post injection, 4 to 8 hours post-injection, 24 to 30 hours post-injection, and 42 to 52 hours post-injection.
| Study group | Role | What they receive |
|---|---|---|
| [203Pb]VMT-α-NET SPECT/CT | Experimental | injection of [203Pb]VMT-α-NET with serialized imaging and dosimetry measurements Receives: Drug: [203Pb]VMT-α-NET; Device: SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
percentage of lesions detected with [203Pb]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.
Measured: Study days 1 through 5
Secondary outcomes (2)
Measure radiation dose from [203Pb]VMT-α-NET dosimetrically
Determine the radiation absorbed dose to the organs and effective dose by pharmacokinetics through imaging and blood-measurements.
Measured: Study days 1 through 5
Single-time point survey
Evaluate the potential of feasibility of single-time point imaging to measure the renal radiation dose
Measured: Study days 1 through 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Aug 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine Tumor Grade 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yusuf Menda
- Sponsor type
- University, hospital or other
- Collaborators
- Perspective Therapeutics, Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Yusuf Menda, University of Iowa
- Investigators
- Yusuf Menda, M.D., Study chair, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111509
- Sponsor's protocol ID
- 202006288
- Other IDs
- 5R01CA243014
- Status last verified
- Jul 2025
- First submitted
- 30 Oct 2021
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared from those patient partners who agree to it. Data will be codified for the investigational team to provided additional details - as necessary - or confirm against source.
Publications
Graves SA, Bushnell DL, Schultz MK, Jain S, Bodeker KL, Menda Y. A Phase 0 Imaging Trial of [203Pb]Pb-VMT-alpha-NET to Enable Dosimetry and Treatment Planning for Refractory or Relapsed Metastatic Neuroendocrine Tumors with [212Pb]Pb-VMT-alpha-NET. J Nucl Med. 2026 Apr 1;67(4):576-583. doi: 10.2967/jnumed.125.270083.
PubMed 41644295
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 First-in-human Clinical Trial of [203Pb]VMT-α-NET SPECT/CT for Somatostatin Receptor Imaging of Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT05111509
- Acronym / sponsor ID
- 202006288
- Keywords
- Alpha Particles, Pb-203 radioisotope, Single Photon Emission Computed Tomography Computed Tomography, SPECT CT Scan
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yusuf MendaUniversity, hospital or other
- Collaborators
- Perspective Therapeutics, Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in man study to determine if [203Pb]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing [212Pb]-based alpha radiation therapy in neuroendocrine therapy.
Detailed description
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 therapy for treatment resistant or refractory neuroendocrine tumors of the foregut or midgut. The first step is to test the imaging agent [203Pb]VMT-α-NET. This requires a very small dose of the drug (microdose) which is then measured by a series of images (like CT scans) over 4 days. Blood samples are also drawn that that time. It is hoped the imaging will identify the tumors so that a therapy using [212Pb]VMT-α-NET can be created.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [203Pb]VMT-α-NET SPECT/CT | Experimental | Drug: [203Pb]VMT-α-NET, Device: SPECT/CTinjection of [203Pb]VMT-α-NET with serialized imaging and dosimetry measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to understand and willingness to provide informed consent
- Stated willingness to comply with all study procedures and availability for duration of study
- Aged ≥ 18 years at the time of study drug administration
- Pathologically confirmed (histology or cytology) well-differentiated neuroendocrine tumor (WHO Grade 1 or 2) with primary location known or believed to be midgut or foregut
- At least 1 somatostatin receptor positive tumor site as demonstrated by PET/CT study utilizing an FDA approved PET agent within 12 months of consent
Key exclusion criteria (8 listed)
- 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).
- 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.
- Therapeutic investigational drug within 4 weeks of C1D1
- Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [203Pb]VMT-α-NET3 to 5 miliCuries of [203]Pb administered intravenously 60 minutes before the start of the scans. | Drug | [203Pb]VMT-α-NET SPECT/CT |
| SPECT/CTScans are administered over 3 days: 1 hour post injection, 4 to 8 hours post-injection, 24 to 30 hours post-injection, and 42 to 52 hours post-injection. | Device | [203Pb]VMT-α-NET SPECT/CT |
Primary outcome
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
Time frame: Study days 1 through 5
percentage of lesions detected with [203Pb]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.
2 secondary outcomes
Measure radiation dose from [203Pb]VMT-α-NET dosimetrically
Time frame: Study days 1 through 5
Single-time point survey
Time frame: Study days 1 through 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 41644295Graves SA, Bushnell DL, Schultz MK, Jain S, Bodeker KL, Menda Y. A Phase 0 Imaging Trial of [203Pb]Pb-VMT-alpha-NET to Enable Dosimetry and Treatment Planning for Refractory or Relapsed Metastatic Neuroendocrine Tumors with [212Pb]Pb-VMT-alpha-NET. J Nucl Med. 2026 Apr 1;67(4):576-583. doi: 10.2967/jnumed.125.270083.
- Individual participant dataSharing planned: Yes. Data will be shared from those patient partners who agree to it. Data will be codified for the investigational team to provided additional details - as necessary - or confirm against source.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Menda, M.D. study chair
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [203Pb]VMT-α-NET and SPECT/CT in people with Neuroendocrine Tumor Grade 2 and Neuroendocrine Tumor Grade 1, run by Yusuf Menda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions (time frame: Study days 1 through 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.