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Granzyme B PET Imaging for Cancer Response Prediction
Study Summary
This trial found that the use of 68Ga-NOTA-hGZP PET imaging is safe in cancer patients undergoing treatment with a checkpoint inhibitor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am allergic to certain drugs similar to [68Ga]-NOTA-hGZP or pembrolizumab.I am not able to become pregnant or have a negative pregnancy test.My metastatic cancer will be treated with specific immune therapy drugs.I am on low-dose steroids but do not have an active autoimmune disease.I am 18 years old or older.I have a tumor that is at least 15 mm wide, or two tumors each at least 15 mm wide.I haven't taken any experimental drugs or treatments in the last 90 days.I am currently breastfeeding.I do not have any health conditions that could affect the study's outcome.I am willing to use birth control during the study.You are expected to live for at least 6 more months.I can care for myself but may not be able to do active work.My side effects from previous treatments have not improved to mild or none.I have cancer that has spread to my brain.I can provide tissue samples from a surgery or biopsy done in the last 90 days.I have previously received a checkpoint inhibitor treatment.
- Group 1: Single Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there still opportunities to participate in this research study?
"Indeed, clinicaltrials.gov attests that this medical experiment is accepting volunteers. It was initially posted on June 16th 2020 and the last modification occured November 25th 2022. 30 participants are sought from 2 locations for this trial."
What is the maximum capacity for participants in this research?
"Affirmative, the information hosted on clinicaltrials.gov confirms this trial's ongoing recruitment of 30 participants across 2 sites. The study was posted on June 16th 2020 and recently updated on November 25th 2022."
What is the projected outcome of this experimental research?
"The primary purpose of this trial, which will be monitored for up to 4-6 hours after injection, is to gauge the number of participants who have changes in their ECG readings. As secondary objectives, researchers are evaluating the absolute number of avid lesions per subject identified by a central reader on PET images, quantifying [68Ga]-NOTA-hGZP accumulation within tumors using region-of-interest analysis and measuring mean standardized uptake value (SUVmean) with no units assigned; they also aim to compare quantified [68Ga]-NOTA-hGZP uptake at 6 months follow up/CT assessments against"
What potential risks could be associated with Single Arm treatments?
"Due to limited evidence of safety and efficacy, Single Arm was rated a 1 on our scale at Power. This is an indication that this trial is in the earliest phase (1)."
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