Clinical trial for Glioblastoma Multiforme (GBM)
Official title Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Glioblastoma Multiform (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC)
ClinicalTrials.gov ID: NCT07733674
What this study is testing
What is 203Pb-RMX-VHPIB injection?
203Pb-RMX-VHPIB injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma multiforme (gbm).
Also referred to as Radiotracer Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are: How does 203Pb-RMX-VH-PIB spread in the body (biodistribution)?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent.
- people aged ≥18 years.
- Karnofsky status ≥60.
- Negative urine pregnancy test in women of childbearing potential.
- Histologically confirmed and /or highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary...
You likely can't join if
- Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.
- Inability to undergo MRI or CT/SPECT/CT scans
- Current somatic or psychiatric disease/condition that may interfere with consent or the objectives and assessments of the study.
- Pregnancy or plans to conceive during the course of study participation.
- In GBM groups participants requiring MRI: History of hypersensitivity or contraindication to gadolinium-based contrast agents, including prior...
- In PDAC groups participants requiring CT scans: Any contraindications to iodinated contrast agents include a history of severe hypersensitivity or...
See the full eligibility criteria
- Signed informed consent.
- people aged ≥18 years.
- Karnofsky status ≥60.
- Negative urine pregnancy test in women of childbearing potential.
- 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...
- Recent blood test results (within 4 weeks pre-dose) as follows:
- WBC: ≥ 2 x 109/L
- Haemoglobin: ≥ 8 g/dL
- Platelets: ≥75 x 109/L
- ALT, AST, AP ≤ 5 times ULN
- Bilirubin: ≤ 2 times ULN
- Creatinine clearance ≥ 60 mL/min, calculated by the Cockcroft-Gault equation
- Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.
- Inability to undergo MRI or CT/SPECT/CT scans
- Current somatic or psychiatric disease/condition that may interfere with consent or the objectives and assessments of the study.
- Pregnancy or plans to conceive during the course of study participation.
- 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...
- 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...
- 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.
- Women who are breastfeeding
- Participants who are currently receiving treatment with statins (HMG-CoA reductase inhibitors), including but not limited to atorvastatin, rosuvastatin, pitavastatin, simvastatin, lovastatin, pravastatin, or...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.