Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)

NCT05823402 | Unknown FDA Device

• 1 other identifier: BAMF-2022-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Dosimetry Method

  To determine the limits of agreements between dosimetry approximation methods and dosimetry using the triexponential fitting method.

  Immediately after the completion of SPECT/CT scanning.

Study Arms (1)

SPECT/CT

EXPERIMENTAL

All patients enrolled will undergo 5 additional (6 total) SPECT/CT scans per treatment cycle. Current FDA approved PSMA radioligand therapy is administered over 6 cycles, so there will be a total of 30 additional SPECT/CT scans during this study. During each treatment cycle, patients will have a SPECT/CT scan at the following time points after administration of PRLT: * 4 Hours * 24 Hours (+/- 8 Hours) * 48 Hours (+/- 8 Hours) * 96 Hours (+/- 8 Hours) * 168 Hours (+/- 24 Hours) * 336 Hours (+/- 24 Hours)

Diagnostic Test: SPECT/CT

Interventions

SPECT/CT DIAGNOSTIC_TEST

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.

SPECT/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male, 18 years old or older
• Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
• 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.
• Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours)

You may not qualify if:

• Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
• 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.

Sponsors & Collaborators

• BAMF Health: lead

Study Sites (1)

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

MeSH Terms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 21, 2023
• Study Start: May 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)