Observational Study of SPECT Imaging for Radiopharmaceutical Therapies

This observational study is looking at how radiation treatments like Radium-223, 177Lu-DOTATATE, and 177Lu-PSMA-617 are distributed in the body. These treatments are used for advanced prostate cancer or other advanced cancers. Researchers will use a special imaging technique called SPECT (Single-Photon Emission Computed Tomography) to see where the radiation goes. The goal is to improve how these treatments are given by understanding the radiation dose to different organs. You could join if you have advanced prostate cancer and are receiving Radium-223, or if you have advanced cancer and are receiving 177Lu-DOTATATE or 177Lu-PSMA-617 as part of your standard care or another study. The main goal is to compare how different imaging methods measure the radiation dose to normal organs over 48 months.

Study design
This is an observational study involving 80 participants. It is not testing a new drug but rather observing current treatments.
What's involved
You would undergo SPECT/CT imaging three times: after the first and last cycles of your planned radiopharmaceutical therapy.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint will be measured at 48 months, indicating a long-term follow-up period.

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NCT06389097

SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization

Recruiting
Not specifiedAges 18+Observational
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~80 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Radium-223177Lu-DOTATATE177Lu-PSMA-617

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean absorbed dose to normal organs compared using different quantitative methods
Measured over 48 months
Prostate Cancer
Advanced Cancer
1 sites across 1 states
Maryland1
  • Ana Kiess, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Eligibility criteria

Inclusion

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
Age \> 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Histologic confirmation of malignancy

Exclusion

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.
  • Mean absorbed dose to normal organs compared using different quantitative methods48 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.