← Back to Search

Radiopharmaceutical

Ga-68-DOTATATE vs. Ga-68-DOTATOC PET Scans for Meningioma

Phase 2
Waitlist Available
Led By Jana Ivanidze, MD/Ph.D
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No contraindications to either radiotracer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 12 months
Awards & highlights

Study Summary

This trial is comparing two types of PET scans to see which is more effective in diagnosing meningiomas.

Who is the study for?
This trial is for adults who are suspected to have meningioma and are preparing for surgery. They must be able to lie still on a scanner table and not have any reasons they can't receive the radiotracers being tested.Check my eligibility
What is being tested?
The study aims to directly compare two imaging agents, Ga-68-DOTATATE and Ga-68-DOTATOC, using PET/CT or PET/MR scans in patients with meningioma to see which provides better information.See study design
What are the potential side effects?
While the document doesn't list specific side effects, similar diagnostic agents may cause mild irritation at the injection site, nausea, or allergic reactions. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have no known allergies or reactions to diagnostic dyes or tracers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Qualitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
Quantitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
Secondary outcome measures
Compare molecular biomarker (EGFR) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (EGFR) results to the maximum SUV ratio of target lesion to cranial blood pool.
Compare molecular biomarker (Ki67) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (Ki67) results to the maximum SUV ratio of target lesion to cranial blood pool.
Compare molecular biomarker (SSTR2 expression) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (SSTR2 expression) results to the maximum SUV ratio of target lesion to cranial blood pool.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with MeningiomaExperimental Treatment2 Interventions
Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,522 Total Patients Enrolled
1 Trials studying Meningioma
200 Patients Enrolled for Meningioma
Cornell UniversityOTHER
166 Previous Clinical Trials
14,089,854 Total Patients Enrolled
Jana Ivanidze, MD/Ph.DPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Meningioma
200 Patients Enrolled for Meningioma

Media Library

Ga-68-DOTATATE (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04298541 — Phase 2
Meningioma Research Study Groups: Patients with Meningioma
Meningioma Clinical Trial 2023: Ga-68-DOTATATE Highlights & Side Effects. Trial Name: NCT04298541 — Phase 2
Ga-68-DOTATATE (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298541 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research been done before?

"Since 2016, Ozmosis Research Inc. has been studying Ga-68-DOTATOC . This earlier research included a 195 person trial which resulted in the N/A drug approval for Ga-68-DOTATOC. Currently, there are 15 active clinical trials being conducted in 19 cities and 13 countries."

Answered by AI

Does the FDA sanction Ga-68-DOTATOC for therapeutic use?

"While Phase 2 trials offer preliminary evidence of safety, there is no data supporting efficacy. For this reason, our company Power has given Ga-68-DOTATOC a score of 2."

Answered by AI

How many people are signing up to participate in this clinical trial?

"That is accurate. The listing on clinicaltrials.gov says that this research is recruiting patients right now. This trial was originally posted on March 18th, 2021 and the most recent update was April 10th, 2022. They are looking for 6 individuals total at just 1 location."

Answered by AI

How do I qualify to participate in this research?

"The requirements for patients that wish to partake in this study is that they have meningioma and are between 18-89 years old. At the moment, the researchers are looking for approximately 6 individuals."

Answered by AI

Are individuals over the age of 20 able to enroll in this clinical research project?

"This trial is for adults aged 18 to 89. If you are a minor or senior, there are other trials that may be more appropriate for you as this study has 15 trials for patients under the age of 18 and 55 for patients over 65."

Answered by AI

What are researchers hoping to achieve through this clinical trial?

"The purpose of this 12-month long study is to compare the results of Ga-68-DOTATATE and -DOTATOC PET scans in order to measure the visual appearance of target lesions in relation to cranial blood pool. Secondary outcomes include comparing molecular biomarker analysis of progesterone receptor, EGFR, and SSTR2 expression with maximum SUV ratio measurements. Patients enrolled in the study will subsequently undergo surgical resection of the lesion in order to assess genetic information through additional staining for research purposes."

Answered by AI

What is the success rate of Ga-68-DOTATOC in human trials?

"As of right now, there are 15 ongoing trials for Ga-68-DOTATOC. 0 of those trials are in Phase 3. While most of the trials for Ga-68-DOTATOC are located in Bethesda, Maryland, there are 47 total locations running trials for this treatment."

Answered by AI

Are we currently enrolling participants for this experiment?

"Yes, the information available on clinicaltrials.gov verifies that this trial is open and recruiting patients. The listing was first published on March 18th 2021 with the latest update being April 10th of this year. They are looking for 6 individuals to participate at 1 location."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medical College of Cornell University
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
2024. "Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04298541.
All > Meningioma
~0 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top