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Trial Title:
Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)
NCT ID:
NCT05823402
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
SPECT/CT
Description:
SPECT/CT imaging can generate 3-dimensional images of the location where the PSMA
radioligand therapy has accumulated in the body. SPECT/CT imaging can also measure doses
of radiation delivered to those locations.
Arm group label:
SPECT/CT
Summary:
The SPECTacular study will enroll patients who are already undergoing a FDA approved
PSMA-targeted Radioligand treatment cycle. During each treatment cycle, patients will
receive 5 additional SPECT/CT scans to investigate the limits of agreement between
dosimetry (absorbed radiation dose) approximation methods and dosimetry using the
triexponential fitting method.
Detailed description:
All patients with PSMA-positive tumor and/or Metastases of Prostate Cancer (PSMA-TMPC)
who would be undergoing a PSMA-targeted Radioligand Therapy (PRLT) based on independent
eligibility criteria for the same, will receive 6 serial SPECT-CT scans for every
treatment cycle as a part of our study. The purpose of this investigation is to assess
the limits of agreement of commonly employed dosimetry methods used to determine or
approximate absorbed doses for organs and tumors compared to a dosimetry method using a
triexponential fit requiring 6 post-injection SPECT-CT scans for all treatment cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the
duration of the study
3. Male, 18 years old or older
4. Histologically or pathologically confirmed prostate adenocarcinoma without
predominant small cell component.
5. Patient is receiving PSMA-targeted Radioligand Therapy (PRLT) for treatment of
PSMA-positive tumor and/or metastases of prostate cancer. Therapy may be FDA
approved or investigational in nature under an approved clinical trial.
6. Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours)
Exclusion Criteria:
1. Assessment by the Investigator as unable or unwilling to comply with the
requirements of the protocol.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
3. All criteria which may preclude a PSMA-radioligand therapy using Lu-177 PSMA-617 or
Lu-177 PSMA I&T to be performed as per standardized guidelines and protocols laid
down for these treatments and per decision by the treating physician.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BAMF Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dan Rogers
Phone:
616-330-3886
Email:
clinical.research@bamfhealth.com
Start date:
May 1, 2023
Completion date:
October 31, 2024
Lead sponsor:
Agency:
BAMF Health
Agency class:
Other
Source:
BAMF Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05823402
