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NCT06777433 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases
A Phase 2 study of Brain Metastases From Solid Tumors, sponsored by Radiopharm Theranostics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT06777433 is a Phase 2 study of Brain Metastases From Solid Tumors that is actively recruiting participants, run by Radiopharm Theranostics. The registered enrollment target is 30 participants. The trial reports 5 study locations across 3 states.
The verdict
NCT06777433, a Phase 2 study of Brain Metastases From Solid Tumors, is actively recruiting participants, sponsored by Radiopharm Theranostics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. 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.
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.
NCT06777433 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Michigan, Illinois, Indiana.
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.
What interventions are being tested in trial NCT06777433?
The interventions under investigation include: RAD101 (18F-FPIA) (DRUG).
Who is sponsoring clinical trial NCT06777433?
This trial is sponsored by Radiopharm Theranostics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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