Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389097
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-24
Brief Title:
SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Single-Photon Emission Computed Tomography SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization SEEtoTREAT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEEtoTREAT
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 SPECTCT 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01CA272222 | NIH | JHM IRB | httpsreporternihgovquickSearchP01CA272222 |
| IRB00411454 | OTHER | None | None |