Triple Negative Breast CancerEarly Phase 1NCT04861077
Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
A Early Phase 1 study testing [18F]FMISO-PET with contrast-enhanced MRI in people with Triple Negative Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- [18F]FMISO-PET with contrast-enhanced MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2027to Aug 2030
- Phase
- Early Phase 1
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years old and ≤ 75 years old
- Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
- >50%Programmed death-ligand 1 (PD-L1) positive
- Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment
- May not be pregnant or breastfeeding
- Subjects must be willing to sign consent
Show all 9Show fewer
- Adequate creatinine clearance per institutional guidelines and within 30 days
- Estimated life expectancy of greater than one year
- Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)
Who cannot join
- Inability to provide informed consent
- Weight over 350 lbs., due to the scanner bore size
- Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study.
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
- Unable to lie still on the imaging table for one (1) hour
- contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
- Have received immunotherapy in the neoadjuvant or adjuvant setting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB
Birmingham, Alabama, 35249
Sebastian Eady, 205-966-2636, smeady@uabmc.edu
About this study
Official title: Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study
This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.
Read the detailed description
Pre-study visit/Consent
This visit will take about 1 hour. Participants will be asked to sign this consent form before any study procedures. Once consented, vital signs will be taken, a blood draw to determine kidney function, and a pregnancy test will be performed for women of childbearing potential. Participants will be asked to fill out an MRI questionnaire and they will be given an additional information sheet on the gadolinium-based contrast agent, Prohance, that the FDA requires for all patients receiving this type of drug. Because the PET/MRI is smaller than most MRI scanners, participants will have a PET/MRI fit test to ensure a proper fit. If eligible for this study, participants will be scheduled for the first PET imaging visit which will occur before they start immunotherapy.
Imaging visits
During this study participants will be scheduled for up to 3 imaging visits. The first imaging visit must be performed before participants start immunotherapy and is necessary for remaining eligible for this study. If, for some reason, the participant misses the following (i.e, 2nd) scheduled imaging visit, they are still eligible to continue in this study as long as they can complete a second imaging visit after finishing the 1st cycle of immunotherapy and before starting the 4th cycle of immunotherapy.
Imaging Visit #1
This visit will take about 4 hours and will take place before the participant starts immunotherapy. No special preparation is required before the study. Upon arrival at the Advanced Imaging Facility (AIF) participants will have a chance to have any remaining questions answered about the procedure. Baseline vital signs, including resting blood pressure, pulse rate, and breathing rate, will be measured and recorded. Women of childbearing potential will have a pregnancy test. An intravenous, plastic catheter will be placed in the arm and participants will be injected with the investigational radioactive drug, [18F]FMISO. Afterwards participants will wait 120 minutes to allow the drug to distribute throughout their body. Participants will then be positioned in the PET/MRI scanner. Based on the PET/MRI fit test, participants will either be positioned face down on their stomach or on their back. Once positioned in the PET/MRI, participants will be imaged for up to 60 minutes during which time they must remain still. During imaging, participants will receive an injection of FDA approved gadolinium-contrast agent called Prohance (gadoteridol) to improve the images.
During any of the imaging visits, if the PET/MRI is unavailable due to scheduling problems or maintenance, participants may be imaged in the PET/CT scanner located in an adjacent room in the AIF. Participants will be scanned for up to 60 minutes. Before or after the PET/CT, but during this visit, participants will receive a separate MRI scan.
When all procedures are complete, the plastic tube will be removed. Unless participants cannot have children because of surgery or other medical reasons, they must agree to use an effective form of birth control for 24 hours after taking the study drug. Effective forms of birth control include birth control pills, patch, intrauterine device (IUD), condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy. Participants may resume normal activities after that 24-hour waiting period. Participants will be contacted by telephone 48 hours after the procedure to make sure they have not had any type of reaction from the investigational drug.
Imaging Visit #2
The second imaging visit will take about 4 hours and will be scheduled after the participant has finished their 1st cycle of immunotherapy and before they start their 2nd cycle.
No special preparation is required before the study. Upon arrival at the Advanced Imaging Facility (AIF) participants will have a chance to have any remaining questions answered about the procedure. Baseline vital signs, including resting blood pressure, pulse rate, and breathing rate, will be measured and recorded. Women of childbearing potential will have a pregnancy test. An intravenous, plastic catheter will be placed in the arm and participants will be injected with the investigational radioactive drug, [18F]FMISO. Afterwards participants will wait 120 minutes to allow the drug to distribute throughout their body. Participants will then be positioned in the PET/MRI scanner. Based on the PET/MRI fit test, participants will either be positioned face down on their stomach or on their back. Once positioned in the PET/MRI, participants will be imaged for up to 60 minutes during which time they must remain still. During imaging, participants will receive an injection of FDA approved gadolinium-contrast agent called Prohance (gadoteridol) to improve the images.
If participants miss this imaging visit but have completed the 1st imaging visit, they are still eligible to continue in this study if they can complete Imaging Visit #3.
When all procedures are complete, the plastic tube will be removed. Unless participants cannot have children because of surgery or other medical reasons, they must agree to use an effective form of birth control for 24 hours after taking the study drug. Effective forms of birth control include birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy. Participants may resume normal activities after that 24-hour waiting period. Participants will be contacted by telephone 48 hours after the procedure to make sure they have not had any type of reaction from the investigational drug.
Imaging Visit #3
The third PET imaging visit will take about 4 hours and will be scheduled after participants finish their 2nd cycle of immunotherapy and before they start their 4th cycle of immunotherapy
No special preparation is required before the study. Upon arrival at the Advanced Imaging Facility (AIF) participants will have a chance to have any remaining questions answered about the procedure. Baseline vital signs, including resting blood pressure, pulse rate, and breathing rate, will be measured and recorded. Women of childbearing potential will have a pregnancy test. An intravenous, plastic catheter will be placed in the arm and participants will be injected with the investigational radioactive drug, [18F]FMISO. Afterwards participants will wait 120 minutes to allow the drug to distribute throughout their body. Participants will then be positioned in the PET/MRI scanner. Based on the PET/MRI fit test, participants will either be positioned face down on their stomach or on their back. Once positioned in the PET/MRI, participants will be imaged for up to 60 minutes during which time they must remain still. During imaging, participants will receive an injection of FDA approved gadolinium-contrast agent called Prohance (gadoteridol) to improve the images.
When all procedures are complete, the plastic tube will be removed. Unless participants cannot have children because of surgery or other medical reasons, they must agree to use an effective form of birth control for 24 hours after taking the study drug. Effective forms of birth control include birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy. Participants may resume normal activities after that 24-hour waiting period. Participants will be contacted by telephone 48 hours after the procedure to make sure they have not had any type of reaction from the investigational drug.
The study team will follow participants for up to 5 years or to disease progression by reviewing their medical records including pathology data obtained from surgery to see how they are doing.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- [18F]FMISO-PET with contrast-enhanced MRI
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FMISO-PET with contrast-enhanced MRIDrug
Triple negative breast cancer patients that are planning to undergo immunotherapy and consent to this study will have 3 imaging visits. Imaging visit 1 will take place before the patients start immunotherapy. Imaging Visit 2 will take place after the patient completes the 1st cycle of immunotherapy and before they start their 2nd cycle. Imaging Visit 3 will take place when the patient completes the 2nd cycle of immunotherapy and before they start the 4th cycle.
| Study group | Role | What they receive |
|---|---|---|
| Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR) | Experimental | The patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 millicuries (mCi)/10milliliters (mL) [18F]FMISO (≤ 15 µg/injected dose) followed by an uptake of 120 minutes.
The injection will be infused nominally over one minute followed by a saline flush. After uptake, the patient will be scanned on the PET/MR for 60 minutes and will receive a contrast injection of gadoteridol during the dynamic sequence of the exam. The patient can be scanned on the PET/CT if the PET/MR is unavailable. During this study patients will be scheduled for up to 3 imaging visits. The first imaging visit will be at baseline prior to starting immunotherapy and is required for study eligibility. If for some reason the patient cannot complete the remaining 2 imaging visits, only one additional imaging visit during the identified times is necessary to remain eligible. Receives: Drug: [18F]FMISO-PET with contrast-enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline measure of PET standardized uptake value (SUV).
Compare baseline metrics from PET/MRI
Measured: Baseline
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Compare baseline metrics from PET/MRI.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study startJun 2027 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna G. Sorace, University of Alabama at Birmingham
- Investigators
- Janis O'Malley, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861077
- Sponsor's protocol ID
- IRB-300007307 R21-072
- Other IDs
- Radiology Research Pilot Award
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study
- ClinicalTrials.gov ID
- NCT04861077
- Acronym / sponsor ID
- IRB-300007307 R21-072
- Conditions
- Triple Negative Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 27 Apr 2021 (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 clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.
Detailed description
Pre-study visit/Consent
This visit will take about 1 hour. Participants will be asked to sign this consent form before any study procedures. Once consented, vital signs will be taken, a blood draw to determine kidney function, and a pregnancy test will be performed for women of childbearing potential. Participants will be asked to fill out an MRI questionnaire and they will be given an additional information sheet on the gadolinium-based contrast agent, Prohance, that the FDA requires for all patients receiving this type of drug. Because the PET/MRI is smaller than most MRI scanners, participants will have a PET/MRI fit test to ensure a proper fit. If eligible for this study, participants will be scheduled for the first PET imaging visit which will occur before they start immunotherapy.
Imaging visits
During this study participants will be scheduled for up to 3 imaging visits. The first imaging visit must be performed before participants start immunotherapy and is necessary for remaining eligible for this study. If, for some reason, the participant misses the following (i.e, 2nd) scheduled imaging visit, they are still eligible to continue in this study as long as they can complete a second imaging visit after finishing the 1st cycle of immunotherapy and before starting the 4th cycle of immunotherapy.
Imaging Visit #1
This visit will take about 4 hours and will take place before the participant starts immunotherapy. No special preparation is required before the study. Upon arrival at the Advanced Imaging Facility (AIF) participants will have a chance to have any remaining questions answered about the procedure. Baseline vital signs, including resting blood pressure, pulse rate, and breathing rate, will be measured and recorded. Women of childbearing potential will have a pregnancy test. An intravenous, plastic catheter will be placed in the arm and participants will be injected with the investigational radioactive drug, [18F]FMISO. Afterwards participants will wait 120 minutes to allow the drug to distribute throughout their body. Participants will then be positioned in the PET/MRI scanner. Based on the PET/MRI fit test, participants will either be positioned face down on their stomach or on their back. Once positioned in the PET/MRI, participants will be imaged for up to 60 minutes during which time they must remain still. During imaging, participants will receive an injection of FDA approved gadolinium-contrast agent called Prohance (gadoteridol) to improve the images.
During any of the imaging visits, if the PET/MRI is unavailable due to scheduling problems or maintenance, participants may be imaged in the PET/CT scanner located in an adjacent room in the AIF. Participants will be scanned for up to 60 minutes. Before or after the PET/CT, but during this visit, participants will receive a separate MRI scan.
When all procedures are complete, the plastic tube will be removed. Unless participants cannot have children because of surgery or other medical reasons, they must agree to use an effective form of birth control for 24 hours after taking the study drug. Effective forms of birth control include birth control pills, patch, intrauterine device (IUD), condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy. Participants may resume normal activities after that 24-hour waiting period. Participants will be contacted by telephone 48 hours after the procedure to make sure they have not had any type of reaction from the investigational drug.
Imaging Visit #2
The second imaging visit will take about 4 hours and will be scheduled after the participant has finished their 1st cycle of immunotherapy and before they start their 2nd cycle.
No special preparation is required before the study. Upon arrival at the Advanced Imaging Facility (AIF) participants will have a chance to have any remaining questions answered about the procedure. Baseline vital signs, including resting blood pressure, pulse rate, and breathing rate, will be measured and recorded. Women of childbearing potential will have a pregnancy test. An intravenous, plastic catheter will be placed in the arm and participants will be injected with the investigational radioactive drug, [18F]FMISO. Afterwards participants will wait 120 minutes to allow the drug to distribute throughout their body. Participants will then be positioned in the PET/MRI scanner. Based on the PET/MRI fit test, participants will either be positioned face down on their stomach or on their back. Once positioned in the PET/MRI, participants will be imaged for up to 60 minutes during which time they must remain still. During imaging, participants will receive an injection of FDA approved gadolinium-contrast agent called Prohance (gadoteridol) to improve the images.
If participants miss this imaging visit but have completed the 1st imaging visit, they are still eligible to continue in this study if they can complete Imaging Visit #3.
When all procedures are complete, the plastic tube will be removed. Unless participants cannot have children because of surgery or other medical reasons, they must agree to use an effective form of birth control for 24 hours after taking the study drug. Effective forms of birth control include birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy. Participants may resume normal activities after that 24-hour waiting period. Participants will be contacted by telephone 48 hours after the procedure to make sure they have not had any type of reaction from the investigational drug.
Imaging Visit #3
The third PET imaging visit will take about 4 hours and will be scheduled after participants finish their 2nd cycle of immunotherapy and before they start their 4th cycle of immunotherapy
No special preparation is required before the study. Upon arrival at the Advanced Imaging Facility (AIF) participants will have a chance to have any remaining questions answered about the procedure. Baseline vital signs, including resting blood pressure, pulse rate, and breathing rate, will be measured and recorded. Women of childbearing potential will have a pregnancy test. An intravenous, plastic catheter will be placed in the arm and participants will be injected with the investigational radioactive drug, [18F]FMISO. Afterwards participants will wait 120 minutes to allow the drug to distribute throughout their body. Participants will then be positioned in the PET/MRI scanner. Based on the PET/MRI fit test, participants will either be positioned face down on their stomach or on their back. Once positioned in the PET/MRI, participants will be imaged for up to 60 minutes during which time they must remain still. During imaging, participants will receive an injection of FDA approved gadolinium-contrast agent called Prohance (gadoteridol) to improve the images.
When all procedures are complete, the plastic tube will be removed. Unless participants cannot have children because of surgery or other medical reasons, they must agree to use an effective form of birth control for 24 hours after taking the study drug. Effective forms of birth control include birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy. Participants may resume normal activities after that 24-hour waiting period. Participants will be contacted by telephone 48 hours after the procedure to make sure they have not had any type of reaction from the investigational drug.
The study team will follow participants for up to 5 years or to disease progression by reviewing their medical records including pathology data obtained from surgery to see how they are doing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR) | Experimental | Drug: [18F]FMISO-PET with contrast-enhanced MRIThe patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 millicuries (mCi)/10milliliters (mL) [18F]FMISO (≤ 15 µg/injected dose) followed by an uptake of 120 minutes. The injection will be infused nominally over one minute followed by a saline flush. After uptake, the patient will be scanned on the PET/MR for 60 minutes and will receive a contrast injection of gadoteridol during the dynamic sequence of the exam. The patient can be scanned on the PET/CT if the PET/MR is unavailable. During this study patients will be scheduled for up to 3 imaging visits. The first imaging visit will be at baseline prior to starting immunotherapy and is required for study eligibility. If for some reason the patient cannot complete the remaining 2 imaging visits, only one additional imaging visit during the identified times is necessary to remain eligible. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be ≥ 18 years old and ≤ 75 years old
- Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
- >50%Programmed death-ligand 1 (PD-L1) positive
- Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment
- May not be pregnant or breastfeeding
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Weight over 350 lbs., due to the scanner bore size
- Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study.
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
- Unable to lie still on the imaging table for one (1) hour
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 |
|---|---|---|
| [18F]FMISO-PET with contrast-enhanced MRITriple negative breast cancer patients that are planning to undergo immunotherapy and consent to this study will have 3 imaging visits. Imaging visit 1 will take place before the patients start immunotherapy. Imaging Visit 2 will take place after the patient completes the 1st cycle of immunotherapy and before they start their 2nd cycle. Imaging Visit 3 will take place when the patient completes the 2nd cycle of immunotherapy and before they start the 4th cycle. | Drug | Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR) |
Primary outcome
Baseline measure of PET standardized uptake value (SUV).
Time frame: Baseline
Compare baseline metrics from PET/MRI
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Time frame: Baseline
Compare baseline metrics from PET/MRI.
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 17 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.
Janis O'Malley, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]FMISO-PET with contrast-enhanced MRI in people with Triple Negative Breast Cancer, run by University of Alabama at Birmingham at 1 site 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 9 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: looking for participants now, as of the sponsor's last update on 17 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 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Sebastian Eady (205-996-2636, smeady@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline measure of PET standardized uptake value (SUV). (time frame: Baseline). The study lists 2 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 17 Aug 2026.