Prostate Cancer(SEEtoTREAT)NCT06389097
SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization
An observational study of Prostate Cancer and Advanced Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prostate Cancer, Advanced Cancer
- What is being tested?
- Radium-223, 177Lu-DOTATATE and 177Lu-PSMA-617
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to Aug 2029
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hopkins/Affiliates inpatients, Hopkins/Affiliates outpatients
Who may be able to join
- Cohort A: Patients with advanced prostate cancer planning to undergo treatment with Radium-223
- Cohort B: Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617
- Eligible patients may be planning to undergo these treatments as part of standard of care or as part of another research protocol
- Age > 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologic confirmation of malignancy
Who cannot join
- Patient is participating in another research protocol that does not allow participation in this imaging protocol or that has schedule of procedures that would not be compatible with this protocol.
- Patient unable to tolerate SPECT scan time, scan frequency, or position.
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
Johns Hopkins University
Baltimore, Maryland, 21287
About this study
Official title: Single-Photon Emission Computed Tomography (SPECT) Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (SEEtoTREAT)
The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy.
Read the detailed description
Radiopharmaceutical therapy (RPT) is an emerging systemic treatment modality that delivers radiation to targeted cells. Recently FDA approved RPT agents include Radium-223 for prostate cancer, 177Lu-DOTATATE for neuroendocrine cancers, and 177Lu-PSMA-617 for prostate cancer. RPT is currently being administered as weight-based or fixed activities for 4-6 cycles, and there is concern that this standardized regimen compromises the potential efficacy of this treatment modality. In large part, this is because rigorous, validated dosimetry methods are not in standard clinical use, especially for alpha emitter RPTs. Such methods using SPECT would make it possible to predict potential normal organ toxicity and tumor response for individual patients. The multidisciplinary Johns Hopkins RPT research group has focused on development of such SPECT dosimetry methods and has an active NIH P01 grant for this work.
The ability to image and understand where the RPT distributes in patients makes it possible to estimate the radiation delivered to tissues. The study team of medical physics experts is developing quantitative 3-D, single-photon emission computed tomography (SPECT) imaging for dosimetry of beta and alpha emitters 1-9. Recognizing that such imaging must be made convenient to be widely adopted, the investigators are also examining the trade-off between simplifying imaging (shorter imaging times, fewer imaging sessions) and the accuracy of the absorbed dose calculations. Key barriers to implementing dosimetry for alpha emitters include the low count-rate and sub-optimal photon emissions and the emission of multiple daughter radionuclides. Currently available reconstruction methods in clinical SPECT systems cannot handle such complex imaging physics. The investigators have pioneered the development of simultaneous multiple radionuclide reconstruction methods for diagnostic applications.
The overall goal of this project is to develop imaging methodologies that may be used to perform accurate RPT dosimetry and treatment planning, especially for alpha emitters. Within this context, the SEE-to-TREAT protocol will provide clinical data and images to validate quantitative reconstruction methods for SPECT imaging.
- Conditions
- Prostate Cancer, Advanced Cancer
- Being tested
- Radium-223, 177Lu-DOTATATE, 177Lu-PSMA-617
- Keywords
- Radium-223, 177Lu-DOTATATE, 177Lu-PSMA-617, SPECT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223Radiation
Radium-223 will be given as per standard of care or other clinical trial. It is typically administered intravenously via slow injection once every 4 weeks with a dosage of 55 kBq/kg per cycle. Patients typically receive up to six cycles unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment.
Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. These will be performed at 2-4 hr, 24 hr, and 48 hr after any cycle of Radium-223. Protocol preference is for imaging with 2 cycles, ideally cycle 1 and cycle 6, but imaging with any one or two cycle(s) is acceptable.
The imaging time at each time point is approximately 30 minutes per field of view with two fields of view (1 hr total) typically collected sequentially (i.e., without repositioning the patient on the imaging table).
177Lu-DOTATATERadiation
177Lu-DOTATATE to be given as Standard of Care (SOC) or other clinical trial. It is typically infused intravenously over a period of 20-60 minutes with peptide co-infusion prior and during the infusion.
Patients will receive 4 cycles of 177Lu-DOTATATE administered approximately every 8 weeks. Treatment cycle is defined as 8 consecutive weeks (D1-D56) following a dose of 177Lu-DOTATATE. Patients receive up to four infusions of 7.4 GBq (200 mCi) every 8 weeks unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment.
Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. Lu-177 SPECT CT will be performed at 24 (D2), 48 (D3), and 96 (D5) of any cycle of therapy.
Imaging time at each time point is ~ 15-22 minutes per field of view with two fields of view (45 min total) typically collected sequentially.
177Lu-PSMA-617Radiation
177Lu-PSMA-617 will be given as per SOC or other clinical trial. It is typically infused intravenously over a period of 20-60 minutes.
Up to 6 cycles of 177Lu- PSMA-617 will be administered approximately every 6 weeks. Treatment cycle is defined as 6 consecutive weeks (D1-D42) following a dose of 177Lu- PSMA-617. Patients will receive up to six infusions of 7.4 GBq (200 mCi) every 6 weeks unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment.
Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. Lu-177 SPECT CT will be performed at 24 (D2), 48 (D3), and 96 (D5) of any cycle of therapy.
Imaging time at each time point is approximately 15-22 minutes per field of view with two fields of view (45 min total) typically collected sequentially.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients with advanced prostate cancer planning to undergo treatment with Radium-223 Receives: Radiation: Radium-223 | |
| Cohort B | Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617 Receives: Radiation: 177Lu-DOTATATE; Radiation: 177Lu-PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absorbed dose to normal organs compared using different quantitative methods
The mean absorbed dose to normal organs (e.g. kidney) will be calculated for each patient and compared using different quantitative reconstruction methods for SPECT imaging.
Measured: 48 months
Secondary outcomes (2)
Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images
The intra-patient and inter-patient variability of mean absorbed dose to normal organs (e.g. kidney) will be calculated. Calculations performed using all 6 SPECT scans per patient will be compared to calculations using a smaller number of SPECT images per patient.
Measured: 48 months
Mean absorbed dose to normal organs correlated with toxicity
The mean absorbed dose to normal organs (e.g. red marrow) will be correlated with toxicity (e.g. maximum CTCAE grade of anemia).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start3 Feb 2025
- Primary completionNov 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ana Kiess, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389097
- Sponsor's protocol ID
- J23152
- Other IDs
- IRB00411454, P01CA272222
- Acronym
- (SEEtoTREAT)
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Photon Emission Computed Tomography (SPECT) Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (SEEtoTREAT)
- ClinicalTrials.gov ID
- NCT06389097
- Acronym / sponsor ID
- (SEEtoTREAT) / J23152
- Conditions
- Prostate Cancer, Advanced Cancer
- Keywords
- Radium-223, 177Lu-DOTATATE, 177Lu-PSMA-617, SPECT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 29 Apr 2024 (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.
The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy.
Detailed description
Radiopharmaceutical therapy (RPT) is an emerging systemic treatment modality that delivers radiation to targeted cells. Recently FDA approved RPT agents include Radium-223 for prostate cancer, 177Lu-DOTATATE for neuroendocrine cancers, and 177Lu-PSMA-617 for prostate cancer. RPT is currently being administered as weight-based or fixed activities for 4-6 cycles, and there is concern that this standardized regimen compromises the potential efficacy of this treatment modality. In large part, this is because rigorous, validated dosimetry methods are not in standard clinical use, especially for alpha emitter RPTs. Such methods using SPECT would make it possible to predict potential normal organ toxicity and tumor response for individual patients. The multidisciplinary Johns Hopkins RPT research group has focused on development of such SPECT dosimetry methods and has an active NIH P01 grant for this work.
The ability to image and understand where the RPT distributes in patients makes it possible to estimate the radiation delivered to tissues. The study team of medical physics experts is developing quantitative 3-D, single-photon emission computed tomography (SPECT) imaging for dosimetry of beta and alpha emitters 1-9. Recognizing that such imaging must be made convenient to be widely adopted, the investigators are also examining the trade-off between simplifying imaging (shorter imaging times, fewer imaging sessions) and the accuracy of the absorbed dose calculations. Key barriers to implementing dosimetry for alpha emitters include the low count-rate and sub-optimal photon emissions and the emission of multiple daughter radionuclides. Currently available reconstruction methods in clinical SPECT systems cannot handle such complex imaging physics. The investigators have pioneered the development of simultaneous multiple radionuclide reconstruction methods for diagnostic applications.
The overall goal of this project is to develop imaging methodologies that may be used to perform accurate RPT dosimetry and treatment planning, especially for alpha emitters. Within this context, the SEE-to-TREAT protocol will provide clinical data and images to validate quantitative reconstruction methods for SPECT imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Radiation: Radium-223Patients with advanced prostate cancer planning to undergo treatment with Radium-223 |
| Cohort B | – | Radiation: 177Lu-DOTATATE, Radiation: 177Lu-PSMA-617Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hopkins/Affiliates inpatients, Hopkins/Affiliates outpatients
Key inclusion criteria (6 listed)
- Cohort A: Patients with advanced prostate cancer planning to undergo treatment with Radium-223
- Cohort B: Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617
- Eligible patients may be planning to undergo these treatments as part of standard of care or as part of another research protocol
- Age > 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (2 listed)
- Patient is participating in another research protocol that does not allow participation in this imaging protocol or that has schedule of procedures that would not be compatible with this protocol.
- Patient unable to tolerate SPECT scan time, scan frequency, or position.
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 |
|---|---|---|
| Radium-223Radium-223 will be given as per standard of care or other clinical trial. It is typically administered intravenously via slow injection once every 4 weeks with a dosage of 55 kBq/kg per cycle. Patients typically receive up to six cycles unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment. Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. These will be performed at 2-4 hr, 24 hr, and 48 hr after any cycle of Radium-223. Protocol preference is for imaging with 2 cycles, ideally cycle 1 and cycle 6, but imaging with any one or two cycle(s) is acceptable. The imaging time at each time point is approximately 30 minutes per field of view with two fields of view (1 hr total) typically collected sequentially (i.e., without repositioning the patient on the imaging table). | Radiation | Cohort A |
| 177Lu-DOTATATE177Lu-DOTATATE to be given as Standard of Care (SOC) or other clinical trial. It is typically infused intravenously over a period of 20-60 minutes with peptide co-infusion prior and during the infusion. Patients will receive 4 cycles of 177Lu-DOTATATE administered approximately every 8 weeks. Treatment cycle is defined as 8 consecutive weeks (D1-D56) following a dose of 177Lu-DOTATATE. Patients receive up to four infusions of 7.4 GBq (200 mCi) every 8 weeks unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment. Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. Lu-177 SPECT CT will be performed at 24 (D2), 48 (D3), and 96 (D5) of any cycle of therapy. Imaging time at each time point is ~ 15-22 minutes per field of view with two fields of view (45 min total) typically collected sequentially. | Radiation | Cohort B |
| 177Lu-PSMA-617177Lu-PSMA-617 will be given as per SOC or other clinical trial. It is typically infused intravenously over a period of 20-60 minutes. Up to 6 cycles of 177Lu- PSMA-617 will be administered approximately every 6 weeks. Treatment cycle is defined as 6 consecutive weeks (D1-D42) following a dose of 177Lu- PSMA-617. Patients will receive up to six infusions of 7.4 GBq (200 mCi) every 6 weeks unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment. Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. Lu-177 SPECT CT will be performed at 24 (D2), 48 (D3), and 96 (D5) of any cycle of therapy. Imaging time at each time point is approximately 15-22 minutes per field of view with two fields of view (45 min total) typically collected sequentially. | Radiation | Cohort B |
Primary outcome
Mean absorbed dose to normal organs compared using different quantitative methods
Time frame: 48 months
The mean absorbed dose to normal organs (e.g. kidney) will be calculated for each patient and compared using different quantitative reconstruction methods for SPECT imaging.
2 secondary outcomes
Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images
Time frame: 48 months
Mean absorbed dose to normal organs correlated with toxicity
Time frame: 48 months
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 30 Mar 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.
Ana Kiess, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Advanced Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 6 inclusion and 2 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 30 Mar 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.
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 Ana Kiess (443-287-7528, akiess1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absorbed dose to normal organs compared using different quantitative methods (time frame: 48 months). 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 30 Mar 2026.