search
Back to results

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

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPECT/CT
Sponsored by
BAMF Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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.

Sites / Locations

  • BAMF HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPECT/CT

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 7, 2023
Last Updated
May 1, 2023
Sponsor
BAMF Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05823402
Brief Title
Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)
Acronym
SPECTacular
Official Title
Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BAMF Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPECT/CT
Arm Type
Experimental
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
SPECT/CT
Intervention 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.
Primary Outcome Measure Information:
Title
Dosimetry Method
Description
To determine the limits of agreements between dosimetry approximation methods and dosimetry using the triexponential fitting method.
Time Frame
Immediately after the completion of SPECT/CT scanning.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Facility Information:
Facility Name
BAMF Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Rogers
Phone
616-330-3886
Email
clinical.research@bamfhealth.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs