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Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases
NCT06777433 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label, single dose, single arm, multicenter Phase 2b study to establish the imaging performance of RAD101 PET in participants who are ≥ 18 years of age and with suspected recurrent brain metastases from solid tumors. The study consists of a 4-week Screening Period, a 3-day Imaging and Safety Follow-Up Period, and a Data Collection Period of up to 6 months. Participant eligibility will be determined during the Screening Period and eligible participants will be enrolled in the study. On Day 1, the enrolled participants will receive a single dose of the investigational medicinal product (IMP), RAD101. Participants will then proceed with a whole brain PET scan. A high-resolution Magnetic Resonance Imaging (MRI) will be performed in joint acquisition with PET or separately on the same day, or on the day prior to or the day following RAD101 administration. For applicable study sites where PK samples will be collected, whole body PET scans will be performed, blood samples will be drawn, and urine will be collected throughout the scanning period. A phone follow-up will be performed on Day 3 (+ 1 day). Participants will have follow-up (longitudinal) MRI (otherwise CT) scans (longitudinal imaging) and/ or a biopsy according to their Standard of Care (SoC). The longitudinal image results, and details of the biopsy if performed as part of SoC (i.e., location and histopathology results), will be collected during the 6- month Data Collection Period.
Conditions Studied
Interventions
- DRUG RAD101 (18F-FPIA)
Study Locations (5)
Michigan
- University of Michigan — Ann Arbor
- Karmanos Cancer Institute — Detroit
- BAMF Health — Grand Rapids
Illinois
- Ascension Illinois Oncology Research — Hoffman Estates
Indiana
- Goshen Center for Cancer Care — Goshen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-12-13 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06777433
The ClinicalTrials.gov registry entry for NCT06777433 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiopharm Theranostics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Brain Metastases From Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which RAD101 (18F-FPIA) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06777433 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Michigan, Illinois, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06777433 about?
NCT06777433 is a clinical study titled "Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases". This is an open-label, single dose, single arm, multicenter Phase 2b study to establish the imaging performance of RAD101 PET in participants who are ≥ 18 years of age and with suspected recurrent brain metastases from solid tumors. The study consists of a 4-week Screening Period, a 3-day Imaging a...
What is the current status of trial NCT06777433?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-12-13. Estimated completion is 2026-06.
What conditions does trial NCT06777433 study?
This clinical trial studies the following conditions: Brain Metastases From Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06777433?
The interventions under investigation include: RAD101 (18F-FPIA) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06777433?
This trial is sponsored by Radiopharm Theranostics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06777433 being conducted?
This trial has 5 study locations across Illinois, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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