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

Sponsor

BAMF Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05823402

Collaborator

(none)

Enrollment

Location

Arm

18.5

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castration-resistant Prostate Cancer	Diagnostic Test: SPECT/CT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Apr 17, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPECT/CT 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 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

Intervention/Treatment

Experimental: SPECT/CT

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

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.

Outcome Measures

Primary Outcome Measures

Dosimetry Method [Immediately after the completion of SPECT/CT scanning.]
To determine the limits of agreements between dosimetry approximation methods and dosimetry using the triexponential fitting method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BAMF Health	Grand Rapids	Michigan	United States	49503

Sponsors and Collaborators

BAMF Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BAMF Health

ClinicalTrials.gov Identifier:

NCT05823402

Other Study ID Numbers:

BAMF-2022-02

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Apr 21, 2023