Effect of Hypoxia on FMISO PET to Response to Lu-177 PSMA Treatment
LuMISO
Effect of 18F-Fluoromisonidazole (18F-FMISO) PET Imaging on Evaluation of Hypoxia Before Lu-177 PSMA Treatment for Prostate Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
It is aimed to evaluate hypoxia before Lu-177 PSMA treatment in prostate cancer and to show its effect on treatment success with 18F-FMISO PET imaging, which allows in-vivo evaluation and quantification of tumor hypoxia, which is known to be one of the factors affecting radiotherapy resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 6, 2024
CompletedFirst Posted
Study publicly available on registry
May 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedMay 29, 2024
May 1, 2024
2 years
May 6, 2024
May 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
To evaluate tumor hypoxia with F-MISO PET to PSA response
Evaluation of the effect of tumor hypoxia to PSA response after Lu-177 PSMA treatment
6. month after radionuclide treatment
To evaluate tumor hypoxia with F-MISO PET to radiological response
Evaluation of the effect of tumor hypoxia to radiological response with RECIST criteria after Lu-177 PSMA treatment
6. month after radionuclide treatment
To evaluate tumor hypoxia with F-MISO PET to PSMA PET response
Evaluation of the effect of tumor hypoxia to PSMA response with RECIP criteria after Lu-177 PSMA treatment
6. month after radionuclide treatment
Study Arms (1)
Treatment arm
EXPERIMENTALPatients who underwent FMISO PET imaging before Lu-177 PSMA radionuclide treatment for CRPC
Interventions
Eligibility Criteria
You may qualify if:
- over 18 years old
- Patients diagnosed with prostate cancer who were referred to our clinic for Lu-177 PSMA treatment and were found suitable for treatment
You may not qualify if:
- Has a life expectancy of less than 3 months
- ECOG\>2
- contraindication for radionuclide treatment with Lu-177 PSMA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cigdem Soydallead
Study Sites (1)
Ankara University Medical School
Ankara, 06580, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Asc Prof of Nuclear Medicine
Study Record Dates
First Submitted
May 6, 2024
First Posted
May 29, 2024
Study Start
February 1, 2024
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
May 29, 2024
Record last verified: 2024-05