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. Approximately 30 participants
will be enrolled in the study. To avoid overrepresentation of a specific tumor type, a
maximum of 15 participants per tumor type will be enrolled: lung, breast, colon, kidney,
or melanoma.
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. All participants will have an MRI (otherwise CT) performed as their SoC within 6
weeks before Day 1. For enrolled participants, the screening MRI images will be collected
and submitted for central imaging review. On Day 1, the enrolled participants will
receive a single dose of the investigational medicinal product (IMP), RAD101, at a target
dose of 370 Megabecquerel (MBq) (10 millicurie (mCi)) ± 10% through a slow intravenous
(IV) bolus injection over a maximum of 30 seconds, followed by a saline flush.
Participants will then proceed with a whole brain PET scan at 60 ± 10 min post-dose. A
high-resolution MRI will be performed in joint acquisition with PET or separately on the
same day. Safety assessments, such as physical examination, vital signs,
Electrocardiogram (ECG), and laboratory tests, will be conducted on Day 1 before RAD101
administration. Vital signs and ECG will be repeated 30 ± 5 min following RAD101
administration on Day 1. A phone follow-up will be performed on Day 3 (+ 1 day).
Participants will have follow-up (longitudinal) MRI scans (longitudinal imaging) and/ or
a biopsy according to their SoC. If a biopsy is performed as part of their SoC during
follow-up, the location of the biopsied lesion(s) and results of histopathology
assessments on the lesion(s) will be collected. The longitudinal MRI results will be
collected for central reading until a SoC biopsy is performed and the histopathology
results are available, or up to 6 months following RAD101 administration, whichever comes
first. The longitudinal MRI 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.
To limit the number of participants being exposed to a dose-ranging study, the minimum
effective dose (MBq) of RAD101 will be assessed on a subset of 6 to 10 participants using
images obtained by simulated count reduction.
The duration of study participation for each participant is approximately 211 days (7
months), including 28 days of the Screening Period, 3 days of the Imaging and Safety
Follow-Up Period, and up to 180 days of the Data Collection Period. The duration of the
entire study is planned to be approximately 15 months.
