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Radiopharmaceutical
SPECT/CT Dosimetry for Prostate Cancer (SPECTacular Trial)
N/A
Recruiting
Research Sponsored by BAMF Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the completion of spect/ct scanning.
Awards & highlights
SPECTacular Trial Summary
This trial will test if radiation doses can be estimated more accurately during PSMA-targeted radioligand therapy. Patients will receive 5 extra scans.
Who is the study for?
Men over 18 with confirmed prostate adenocarcinoma, who can lay flat for up to 2 hours and are undergoing PSMA-targeted Radioligand Therapy. They must consent to study procedures and be available throughout the study. Those with performance status ≥2 or conditions preventing standard Lu-177 PSMA therapy cannot participate.Check my eligibility
What is being tested?
The SPECTacular Study is testing additional SPECT/CT scans in patients already receiving PSMA-targeted Radioligand treatments for prostate cancer. It aims to compare different methods of measuring absorbed radiation doses during treatment cycles.See study design
What are the potential side effects?
While the trial focuses on imaging techniques rather than new medications, potential side effects may stem from prolonged exposure to radioligands used in therapy, such as fatigue, nausea, dry mouth or changes in blood counts.
SPECTacular Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after the completion of spect/ct scanning.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the completion of spect/ct scanning.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dosimetry Method
SPECTacular Trial Design
1Treatment groups
Experimental Treatment
Group I: SPECT/CTExperimental Treatment1 Intervention
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPECT/CT
2014
N/A
~50
Find a Location
Who is running the clinical trial?
BAMF HealthLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My physical functioning is somewhat limited.My doctor agrees I can have PSMA-radioligand therapy.I am a man aged 18 or older.I can lay flat without moving for up to 2 hours.I am undergoing a specific therapy for prostate cancer that targets PSMA.My prostate cancer is confirmed without a major small cell component.
Research Study Groups:
This trial has the following groups:- Group 1: SPECT/CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available berths in this clinical trial?
"As verified on clinicaltrials.gov, recruitment for the trial is still ongoing. This medical project was initially announced April 17th 2023 and amended two days later."
Answered by AI
How many participants are registered for this experiment?
"Correct. According to clinicaltrials.gov, this study posted on April 17th of 2023 is currently recruiting participants. 30 volunteers are expected from 1 site in total."
Answered by AI
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