Brain Metastases From Solid TumorsPhase 2RAD101NCT06777433
Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases
A Phase 2 study testing RAD101 (18F-FPIA) in people with Brain Metastases From Solid Tumors, run by Radiopharm Theranostics, Ltd at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases From Solid Tumors
- What is being tested?
- RAD101 (18F-FPIA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Dec 2024to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥ 18 years of age at the time of signing the informed consent.
- Participant has one of the following histopathologically confirmed advanced solid tumors with known history of brain metastases: lung, breast, colon, kidney, or melanoma, and with known history of brain metastases. Other primary tumor diagnoses may be approved on a case-by-case basis following discussion with the Sponsor.
- Participant has undergone SRS or SRT for their brain metastases prior to study screening with pre-planning images available for submission to the centralized imaging reader as reference.
- Participant has suspected but not confirmed recurrent brain metastases in at least 1 lesion previously treated with SRS or SRT, based on gadolinium-enhanced volumetric MRI (MRI preferred, otherwise CT) within 8 weeks prior to Day 1, with post-SRS/SRT images available for submission to the centralized imaging reader as reference. If the SoC scan was performed > 8 weeks before Day 1, discussion with the Sponsor is required to determine eligibility. In addition, each suspected lesion must meet the following criteria:
- Size must be at least 5 mm in longest diameter seen on 2 slices on the volumetric MRI analyzed at 2.5 mm slice thickness, AND
- Lesion does not meet complete response criteria or unequivocal progressive disease criteria in the medical opinion of the evaluating provider or as outlined in Appendix 5 (Section 10.5).
Show all 21Show fewer
- Note: New brain metastases or new leptomeningeal disease based on macrocyclic gadolinium-enhanced MRI within 6 weeks prior to Day 1, in addition to the above findings, are permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Estimated glomerular filtration rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and individualized for participant's body surface area (BSA) ≥ 45 ml/min (ie, nonindexed GFR = indexed GFR × BSA (m2)/1.73 m2)
- Life expectancy ≥4 months
- Participant is not scheduled to undergo a confirmatory biopsy to characterize MRI findings until after the Day 1 study procedures have been completed.
- Female participants must meet either of the following criteria:
- Women of childbearing potential (WOCBP) must have a negative beta human chorionic gonadotropin (β-hCG) test within 72 hours before administration of IMP and must not be breastfeeding. WOCBP, defined as all women physiologically capable of becoming pregnant, should agree to use highly effective methods of contraception during dosing and for 12 hours after administration of RAD101.
- Women who are not of childbearing potential are those who are surgically sterile or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during dosing and for 12 hours after administration of IMP. All male participants must agree to not donate sperm for 12 hours after administration of IMP.
- Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (i.e., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had bilateral surgical oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
- Male sterilization (at least 6 months prior to Screening). The vasectomized male partner should be the sole partner for that participant and the absence of sperm should be confirmed.
- Use of oral, injected, or implanted hormonal methods of contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that inhibit ovulation and have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking IMP. Acceptable contraception methods are further described in the protocol.
- Willing and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF), and willing to comply with all study procedures.
Who cannot join
- History of known additional malignancy that is progressing or requires treatment.
- Brain surgery for the target lesion within 4 weeks before the screening MRI.
- Whole brain Radiation Therapy (RT), SRT, or SRS within 6 weeks of Day 1
- Baseline Fridericia-corrected QT interval (QTcF) > 470 msec or history of congenital long QT syndrome
- Any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures, such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, and participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures.
- Participation in any other investigational trial from the time of informed consent signature to the end of the Imaging and Safety Follow-Up Period if participation in the other study would interfere with the current study or would not be allowed by the other study. Participation in another study should be discussed with the Sponsor.
- History of uncontrolled allergic reactions and/or known or expected hypersensitivity to RAD101, or any of its excipients, and/or macrocyclic gadolinium-based contrast agents.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Karmanos Cancer Institute
Detroit, Michigan, 48201
Goshen Center for Cancer Care
Goshen, Indiana, 46526
BAMF Health
Grand Rapids, Michigan, 49503
Ascension Illinois Oncology Research
Hoffman Estates, Illinois, 60169
About this study
Official title: An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants With Suspected Recurrent Brain Metastases From Solid Tumors
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.
Read the detailed description
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 a post-SRS (stereotactic radiosurgery)/ SRT (stereotactic radiotherapy) MRI (otherwise CT) performed as their SoC within 8 weeks before Day 1. For enrolled participants, the screening MRI (otherwise CT) 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, or on the day prior 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. 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 at the end of infusion (for participants undergoing PK assessments) 35 ± 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 (otherwise CT) 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 image 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 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.
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.
- Conditions
- Brain Metastases From Solid Tumors
- Being tested
- RAD101 (18F-FPIA)
- Keywords
- Brain Metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD101 (18F-FPIA)Drug
A single dose of 18F-RAD101 with a maximum of 370 MBq (10 mCi) administered as a slow IV bolus injection over a maximum of 30 seconds, followed by a saline flush.
| Study group | Role | What they receive |
|---|---|---|
| RAD101 (18F-Fluorescence polarization immunoassay (FPIA)) | Experimental | 370 MBq (10 mCi) single dose administered at Day 1 visit Receives: Drug: RAD101 (18F-FPIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
Number, size, and proportion of SRS/SRT-treated lesions identified by both RAD101 PET/MRI and MRI (with macrocyclic gadolinium)
Measured: 1 Week
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
Number, size, and proportion of SRS/SRT-treated lesions identified by RAD101 PET/MRI and not identified by MRI (with macrocyclic gadolinium)
Measured: 1 Week
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
Number, size, and proportion of SRS/SRT-treated lesions not identified by RAD101 PET/MRI and identified by MRI (with macrocyclic gadolinium)
Measured: 1 Week
Secondary outcomes (7)
Accuracy of RAD101 in identifying tumor recurrence versus radiation necrosis in previously SRS-treated brain metastasis
Standard of care imaging using longitudinal MRI scans or histopathology based on RANO-BM response criteria
Measured: 6 months
Safety and tolerability of a single dose of RAD101
The properties, incidence, nature and severity of AEs and SAEs per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 48 Hours
Optimal dose of RAD101
Activity (MBq) of RAD101 in images obtained by simulated count reduction
Measured: 1 week
Performance of RAD101 PET in identifying tumor lesions
Maximum standardized uptake values (Standardized uptake value (SUV)max) in suspected tumor lesions
Measured: 1 week
Performance of RAD101 PET in identifying tumor lesions
Mean standardized uptake value (SUVmean) in tumor lesions
Measured: 1 week
Performance of RAD101 PET in identifying tumor lesions
Lesion SUVmean to normal brain SUVmean ratio
Measured: 1 week
Performance of RAD101 PET in identifying tumor lesions
Lesion SUVmax to normal brain SUVmax ratio
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start13 Dec 2024
- Primary completion23 Apr 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases From Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiopharm Theranostics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Dimitris Voliotis, MD, Study director, Radiopharm Theranostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777433
- Sponsor's protocol ID
- GCP-PRT-101-001
- Acronym
- RAD101
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants With Suspected Recurrent Brain Metastases From Solid Tumors
- ClinicalTrials.gov ID
- NCT06777433
- Acronym / sponsor ID
- RAD101 / GCP-PRT-101-001
- Conditions
- Brain Metastases From Solid Tumors
- Keywords
- Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radiopharm Theranostics, LtdIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 a post-SRS (stereotactic radiosurgery)/ SRT (stereotactic radiotherapy) MRI (otherwise CT) performed as their SoC within 8 weeks before Day 1. For enrolled participants, the screening MRI (otherwise CT) 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, or on the day prior 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. 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 at the end of infusion (for participants undergoing PK assessments) 35 ± 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 (otherwise CT) 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 image 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 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD101 (18F-Fluorescence polarization immunoassay (FPIA)) | Experimental | Drug: RAD101 (18F-FPIA)370 MBq (10 mCi) single dose administered at Day 1 visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Must be ≥ 18 years of age at the time of signing the informed consent.
- Participant has one of the following histopathologically confirmed advanced solid tumors with known history of brain metastases: lung, breast, colon, kidney, or melanoma, and with known history of brain metastases. Other primary tumor diagnoses may be approved on a case-by-case basis following discussion with the Sponsor.
- Participant has undergone SRS or SRT for their brain metastases prior to study screening with pre-planning images available for submission to the centralized imaging reader as reference.
- Participant has suspected but not confirmed recurrent brain metastases in at least 1 lesion previously treated with SRS or SRT, based on gadolinium-enhanced volumetric MRI (MRI preferred, otherwise CT) within 8 weeks prior to Day 1, with post-SRS/SRT images available for submission to the centralized imaging reader as reference. If the SoC scan was performed > 8 weeks before Day 1, discussion with the Sponsor is required to determine eligibility. In addition, each suspected lesion must meet the following criteria:
- Note: New brain metastases or new leptomeningeal disease based on macrocyclic gadolinium-enhanced MRI within 6 weeks prior to Day 1, in addition to the above findings, are permitted.
Key exclusion criteria (7 listed)
- History of known additional malignancy that is progressing or requires treatment.
- Brain surgery for the target lesion within 4 weeks before the screening MRI.
- Whole brain Radiation Therapy (RT), SRT, or SRS within 6 weeks of Day 1
- Baseline Fridericia-corrected QT interval (QTcF) > 470 msec or history of congenital long QT syndrome
- Any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures, such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, and participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD101 (18F-FPIA)A single dose of 18F-RAD101 with a maximum of 370 MBq (10 mCi) administered as a slow IV bolus injection over a maximum of 30 seconds, followed by a saline flush. | Drug | RAD101 (18F-Fluorescence polarization immunoassay (FPIA)) |
Primary outcome
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
Time frame: 1 Week
Number, size, and proportion of SRS/SRT-treated lesions identified by both RAD101 PET/MRI and MRI (with macrocyclic gadolinium)
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
Time frame: 1 Week
Number, size, and proportion of SRS/SRT-treated lesions identified by RAD101 PET/MRI and not identified by MRI (with macrocyclic gadolinium)
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
Time frame: 1 Week
Number, size, and proportion of SRS/SRT-treated lesions not identified by RAD101 PET/MRI and identified by MRI (with macrocyclic gadolinium)
7 secondary outcomes
Accuracy of RAD101 in identifying tumor recurrence versus radiation necrosis in previously SRS-treated brain metastasis
Time frame: 6 months
Safety and tolerability of a single dose of RAD101
Time frame: 48 Hours
Optimal dose of RAD101
Time frame: 1 week
Performance of RAD101 PET in identifying tumor lesions
Time frame: 1 week
Performance of RAD101 PET in identifying tumor lesions
Time frame: 1 week
Performance of RAD101 PET in identifying tumor lesions
Time frame: 1 week
Performance of RAD101 PET in identifying tumor lesions
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitris Voliotis, MD study director
Radiopharm Theranostics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD101 (18F-FPIA) in people with Brain Metastases From Solid Tumors, run by Radiopharm Theranostics, Ltd at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium (time frame: 1 Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.