Can a radioactive tracer light up hidden tumors? a new trial aims to find out
NCT ID NCT07733674
First seen Jul 29, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This Phase I trial is testing an experimental imaging drug, 203Pb-RMX-VH-PIB, to see how it spreads through the body and how much radiation reaches different organs. The study includes adults with glioblastoma (a type of brain cancer) or pancreatic cancer. Participants receive a single injection of the radioactive tracer followed by multiple SPECT/CT scans to map its distribution and measure radiation exposure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a radioactive imaging drug called 203Pb-RMX-VH-PIB
- What this could lead to
- If successful, this imaging approach could help doctors see tumors more clearly and plan better treatments for brain and pancreatic cancers.
- What could go wrong
- This is a very early, small Phase I trial with only 20 participants, so it is not designed to prove effectiveness. The radioactive tracer may not distribute as expected or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent. 2. Subjects aged ≥18 years. 3. Karnofsky status ≥60. 4. Negative urine pregnancy test in women of childbearing potential. 5. Histologically confirmed and /or highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary, recurrent or stable enhancing residual or primary, recurrent or stable enhancing residual PDAC. a. GBM group i. Contrast enhanced Brain MRI image with results compatible with GBM within the 2 weeks of dosing day. ii. Tumor size of ≥ 1.0 cm in any dimension by MRI. iii. No antiangiogenic therapy within 4 weeks of the day of dosing. iv. No chemotherapy within 2 weeks of the day of dosing. v. Subjects receiving corticosteroids must be on a stable or decreasing dose regimen prior to enrollment b. PDAC group i. No chemotherapy within 2 weeks of the day of dosing ii. Tumor size of ≥ 1.0 cm in any dimension by MRI or CT 6. Recent blood test results (within 4 weeks pre-dose) as follows: 1. WBC: ≥ 2 x 109/L 2. Haemoglobin: ≥ 8 g/dL 3. Platelets: ≥75 x 109/L 4. ALT, AST, AP ≤ 5 times ULN 5. Bilirubin: ≤ 2 times ULN 6. Creatinine clearance ≥ 60 mL/min, calculated by the Cockcroft-Gault equation Exclusion Criteria: 1. Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB. 2. Inability to undergo MRI or CT/SPECT/CT scans 3. Current somatic or psychiatric disease/condition that may interfere with consent or the objectives and assessments of the study. 4. Pregnancy or plans to conceive during the course of study participation. 5. In GBM groups participants requiring MRI: History of hypersensitivity or contraindication to gadolinium-based contrast agents, including prior allergic or anaphylactoid reactions to gadolinium contrast media, or any condition (e.g., severe renal impairment, acute kidney injury) that, in the investigator's judgment, increases the risk associated with gadolinium administration. 6. In PDAC groups participants requiring CT scans: Any contraindications to iodinated contrast agents include a history of severe hypersensitivity or allergic reaction to iodinated contrast media, significant renal impairment (e.g., eGFR \< 30 mL/min/1.73 m² or acute kidney injury), uncontrolled hyperthyroidism or other thyroid disorders that may worsen with iodine exposure, prior contrast-induced nephropathy, pregnancy, and any unstable medical condition such as severe heart failure or hemodynamic instability that, in the investigator's judgment, increases the risk of contrast administration. 7. Male and female participants of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of the study. 8. Women who are breastfeeding 9. Participants who are currently receiving treatment with statins (HMG-CoA reductase inhibitors), including but not limited to atorvastatin, rosuvastatin, pitavastatin, simvastatin, lovastatin, pravastatin, or fluvastatin, are excluded unless the medication has been discontinued for at least four (4) drug half-lives prior to administration of the investigational product
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Excel Diagnostics & Nuclear Oncology Center
RECRUITINGHouston, Texas, 77042, United States
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