SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization
- Conditions
- Prostate CancerAdvanced Cancer
- Interventions
- Radiation: 177Lu-DOTATATERadiation: Radium-223Radiation: 177Lu-PSMA-617
- Registration Number
- NCT06389097
- Brief 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
-
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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort B 177Lu-DOTATATE Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617 Cohort A Radium-223 Patients with advanced prostate cancer planning to undergo treatment with Radium-223 Cohort B 177Lu-PSMA-617 Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617
- Primary Outcome Measures
Name Time Method Mean absorbed dose to normal organs compared using different quantitative methods 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.
- Secondary Outcome Measures
Name Time Method Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images 48 months 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.
Mean absorbed dose to normal organs correlated with toxicity 48 months The mean absorbed dose to normal organs (e.g. red marrow) will be correlated with toxicity (e.g. maximum CTCAE grade of anemia).
Trial Locations
- Locations (1)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States