68-Ga HA-DOTATATE PET/CT for Cranial Arteritis

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Alberta, Edmonton, Canada
Cranial Arteritis+2 More
68-Ga HA-DOTATATE PET/CT - DiagnosticTest
Eligibility
18+
All Sexes
Eligible conditions
Cranial Arteritis

Study Summary

This study is evaluating whether a PET scan with a radioactive tracer can be used to identify areas of inflammation in the blood vessels of people with giant cell arteritis.

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Eligible Conditions

  • Cranial Arteritis
  • Giant Cell Arteritis
  • Polymyalgia Rheumatica
  • Arteritis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 68-Ga HA-DOTATATE PET/CT will improve 1 primary outcome and 4 secondary outcomes in patients with Cranial Arteritis. Measurement will happen over the course of time 0 (baseline).

0 and 6 months
Correlation between vascular DOTATATE uptake scores and clinical status
Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure
6 months
Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)
time 0 (baseline)
Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)
Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
DOTATATE

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. 68-Ga HA-DOTATATE PET/CT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

DOTATATE
DiagnosticTest
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

University of Alberta - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cranial Arteritis or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Meet the revised GCA diagnosis criteria (modified from ref 1)
Have either newly-diagnosed or relapsing disease
Have active disease (modified from ref 1, to remove ESR/CRP requirements)
Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.
GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).
Age ≥ 50 years
Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery tenderness, ischemia-related vision loss, jaw/mouth claudication
Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
Temporal artery biopsy revealing features of GCA

Patient Q&A Section

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

What causes cranial arteritis?

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There is some debate whether cranial arteritis is a definite disorder, a form of vasculitis, a separate condition which overlaps with ANCA-associated vasculitides, or a spectrum of diseases similar to giant-cell arteritis. There is preliminary support for the last possibility.

Unverified Answer

How many people get cranial arteritis a year in the United States?

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Approximately 47,000 persons annually in the United States are diagnosed with cranial arteritis. Cranial arteritis affects males and females equally. The highest prevalence of cranial arteritis is in the 50-59 age group.

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What are the signs of cranial arteritis?

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Signs of cranial arteritis may include sudden and persistent headache, visual disturbances, or abnormal postural changes or gaze strabismus. The presence of cranial arteritis in all cases should prompt consideration of underlying inflammatory causes.

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What are common treatments for cranial arteritis?

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A review of the use of oral treatment for patients with cranial arteritis was completed and analyzed. Although NSAIDS are the most frequently prescribed treatment for cranial arteritis, their effects could be life-threatening. This may affect the duration of disease, the rate of a relapse in the future, or a patient's life span. Another treatment method is, however, the corticosteroids injections which may have a positive effect on the duration of the disease and may have a lower risk of relapse. While these patients may often endure pain, patients with cerebral arteritis suffer from a high rate of anxiety and can develop a seizure. The pain from this disease can therefore be devastating for these victims.

Unverified Answer

Can cranial arteritis be cured?

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Cranial arteritis cannot be cured. With good treatment, symptoms can be reduced in most cases. But if not treated, the patient will continue experiencing stroke-like symptoms or even permanent brain damage. For this reason, cranial arteritis should not be neglected.

Unverified Answer

What is cranial arteritis?

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Our retrospective literature review indicates the increased frequency of brain lesion in CPA syndrome, but there has never been a case report that indicates the direct causal relation between this diagnosis and CPA. Nevertheless, these findings strongly suggest the concept of CPA as a systemic vasculitic syndrome rather than a specific disorder that primarily involves cranial vessels.

Unverified Answer

Does 68-ga ha-dotatate pet/ct improve quality of life for those with cranial arteritis?

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68Ga DOT PET/CT improved QOL over 6 months compared with 18Ga DOT PET /CT in patients with active cranial arteritis. These preliminary results of 68Ga DOT PET/CT support a role for PET/CT in the evaluation and treatment of patients with cranial arteritis.

Unverified Answer

What are the common side effects of 68-ga ha-dotatate pet/ct?

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It is important for clinicians to anticipate and recognize some of the common side effects of 68Ga dotatate PET and CPT as they could lead to an important clinical change. Those side effects are a headache, headache with dizziness, nausea, vomiting, and diarrhea. They seem to be transient, last less than 3 hours, and they can be safely managed. Nevertheless, they deserve monitoring during the 6 to 24 hours after their resolution. We recommend a clinical care audit to collect patient's medical history to monitor these side effects. This might provide additional tools to guide diagnosis, treatment, and follow-up in patients with suspected CVS.

Unverified Answer

What is the latest research for cranial arteritis?

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Patients must keep their doctors informed on important news and findings that could help with their condition (CAs). The latest research updates for CAs can be found at [Powermedicine.com|Powermedicine.com]](http://powermedicine.com/brain-and-immune). CAs can be extremely life-threatening illnesses that occur when immune system attacks the wall of blood vessels around the brain - that's when cranial arteritis is diagnosed.

Unverified Answer

How does 68-ga ha-dotatate pet/ct work?

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68-Gad is known to be used to diagnose, stage, and monitor cancers such as medulloblastomas and kidney cancer because it is absorbed by cancer cells, thereby enhancing their uptake while sparing normal tissues from being harmed. Results of this trial in a mouse xenograft model suggest that 68-Gad PET may be useful in the detection of granulomatous disease related to the treatment of sarcoidosis with corticosteroids. In addition, we show that use of 68-Gad in this study reduced the number of false-positive scans and increased the number of patients found to be positive for sarcoidosis and other disease.

Unverified Answer

Is 68-ga ha-dotatate pet/ct typically used in combination with any other treatments?

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Gadolinium-based MRI contrast agents (GBCA) are typically used in combination with other methods. However, this approach often produces clinically desirable improvement in gadolinium-positive patients who are treated with multiple previous therapies.

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Who should consider clinical trials for cranial arteritis?

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In the absence of conclusive evidence for treatment of primary cranial arteritis, it is appropriate for clinicians to consider participation in a trial to assess the overall effectiveness of a treatment regimen.

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