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Radiopharmaceutical

68-Ga HA-DOTATATE PET/CT for Giant Cell Arteritis

Phase 2
Waitlist Available
Led By Alison Clifford
Research Sponsored by University of Alberta
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 6 months
Awards & highlights

Study Summary

This trial will compare the use of two different PET scans to see which one is better at identifying areas of active inflammation in patients with giant cell arteritis.

Eligible Conditions
  • Giant Cell Arteritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)
Secondary outcome measures
Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)
Correlation between vascular DOTATATE uptake scores and clinical status
Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DOTATATEExperimental Treatment1 Intervention
All 15 GCA patients will undergo 68-Ga HA-DOTATATE PET/CT imaging at baseline, in addition to FDG PET/CTA (as part of standard of care). DOTATATE PET/CT imaging will be repeated at 6 months follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68-Ga HA-DOTATATE PET/CT
2019
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,769 Total Patients Enrolled
Alison CliffordPrincipal InvestigatorUniversity of Alberta

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 openings for enrolment in this clinical trial?

"That is accurate. The clinical trial, as advertised on clinicaltrials.gov, has an open call for 15 patients from a single site. The study was established on September 9th, 2019 and updated most recently on April 7th, 2022."

Answered by AI

Has 68-Ga HA-DOTATATE PET/CT received FDA approval?

"This particular medical imaging technique, 68-Ga HA-DOTATATE PET/CT, is classified as a Phase 2 trial. This means that while there is some data supporting its safety, none of the clinical trials conducted thus far have been effective in demonstrating its efficacy."

Answered by AI
Recent research and studies
International Journal of RheumatologyJournal
Design of the Tocilizumab in Giant Cell Arteritis Trial
Unizony, Sebastian H., Bhaskar Dasgupta, Elena Fisheleva, Lucy Rowell, Georg Schett, Robert Spiera, Jochen Zwerina, Olivier Harari, and John H. Stone. 2013. “Design of the Tocilizumab in Giant Cell Arteritis Trial”. International Journal of Rheumatology. Hindawi Limited. doi:10.1155/2013/912562.
clinicaltrials.govStudy
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
2019. "Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03812302.
~2 spots leftby Apr 2025
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