Clinical trial · Interventional
A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent
A Phase 0 First-in-human Clinical Trial of [203Pb]VMT-α-NET SPECT/CT for Somatostatin Receptor Imaging of Neuroendocrine Tumors
NCT05111509CI-TRIAL-00092106active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumor Grade 1 | Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Neuroendocrine Tumor Grade 2 | Neuroendocrine Tumor G2 | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [203Pb]VMT-α-NET | Drug | — | UNRESOLVED |
| SPECT/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [203Pb]VMT-α-NET SPECT/CT
- description
- injection of \[203Pb\]VMT-α-NET with serialized imaging and dosimetry measurements
- interventionNames
- Drug: [203Pb]VMT-α-NET
- Device: SPECT/CT
Primary outcomes (1)
- measure
- Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
- timeFrame
- Study days 1 through 5
- description
- percentage of lesions detected with \[203Pb\]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.
Secondary outcomes (2)
- measure
- Measure radiation dose from [203Pb]VMT-α-NET dosimetrically
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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). * 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.
References
Publications (1)
- DERIVEDGraves 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. PMID 41644295