NCT06389097 SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization
| NCT ID | NCT06389097 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-02-03 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Ana Kiess, MD, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06389097 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06389097 currently recruiting?
Yes, NCT06389097 is actively recruiting participants. Contact the research team at akiess1@jhmi.edu for enrollment information.
Where is the NCT06389097 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06389097 clinical trial?
NCT06389097 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Ana Kiess, MD, PhD at Johns Hopkins University. The trial plans to enroll 80 participants.
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