← Back to Search

68Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Phase 2

Recruiting

Led By Jonathan Abele, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-scan

Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of a new radioisotope for imaging tumors. The new radioisotope is produced at the Edmonton Radiopharmaceutical Centre.

Who is the study for?

This trial is for patients with suspected or confirmed somatostatin receptor positive tumors, such as certain neuroendocrine tumors. Participants must have had a CT or MRI within the last 6 months and be able to consent. It's not for those who've had allergic reactions to DOTATATE, weigh over 225 kg, can't lie still for imaging due to conditions like extreme claustrophobia, or lack intravenous access.Check my eligibility

What is being tested?

The study tests the safety and diagnostic effectiveness of a new imaging agent called 68Ga-HA-DOTATATE in detecting somatostatin receptor positive tumors using PET scans. This could potentially offer better image quality and accuracy compared to older methods.See study design

What are the potential side effects?

While specific side effects are not listed, potential risks may include allergic reactions similar to previous allergies to DOTATATE or related compounds. The procedure involves lying still during PET scanning which might cause discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy - sensitivity

Efficacy - specificity

Secondary outcome measures

Safety - adverse events - delayed

Safety - adverse events - immediate

Safety - adverse events - post-scan

Trial Design

1Treatment groups

Experimental Treatment

Group I: 68Ga-HA-DOTATATE PET/CT scanExperimental Treatment1 Intervention

2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

384,534 Total Patients Enrolled

3 Trials studying Neuroendocrine Tumors

1,250 Patients Enrolled for Neuroendocrine Tumors

Jonathan Abele, MDPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

800 Total Patients Enrolled

1 Trials studying Neuroendocrine Tumors

800 Patients Enrolled for Neuroendocrine Tumors

Media Library

68Ga-HA-DOTATATE Clinical Trial Eligibility Overview. Trial Name: NCT04888481 — Phase 2

Neuroendocrine Tumors Research Study Groups: 68Ga-HA-DOTATATE PET/CT scan

Neuroendocrine Tumors Clinical Trial 2023: 68Ga-HA-DOTATATE Highlights & Side Effects. Trial Name: NCT04888481 — Phase 2

68Ga-HA-DOTATATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04888481 — Phase 2

Frequently Asked Questions

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

Is the utilization of 68Ga-HA-DOTATATE secure for individuals?

"Our evaluation of 68Ga-HA-DOTATATE gives it a score of 2 due to its Phase 2 classification, indicating there is some evidence backing safety but none for efficacy."

Answered by AI

What empirical evidence exists regarding the efficacy of 68Ga-HA-DOTATATE?

"As of now, there are 15 active clinical trials evaluating 68Ga-HA-DOTATATE, with none in Phase 3. Most studies for this substance originate from Bethesda, MD but the research is also being conducted at 47 different sites."

Answered by AI

Are any more participants being accepted for this research project?

"Patient recruitment for this clinical trial is currently in progress. According to the information posted on clinicaltrials.gov, it was launched on February 15th 2022 and last modified April 11th of the same year."

Answered by AI

Is this trial pioneering a new method or technique?

"Exploration and research of 68Ga-HA-DOTATATE has been ongoing since 2016, when Ozmosis Research Inc. sponsored a study with 195 participants that eventually led to its N/A drug approval. Nowadays, 15 studies are taking place across 19 cities within 13 countries."

Answered by AI

How many participants are being enrolled in this research protocol?

"Indeed, according to clinicaltrials.gov the medical research was first posted on February 15th 2022 and is still actively seeking participants as of April 11th 2022. The trial necessitates 600 volunteers at one particular site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors

2022. "68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04888481.

All > Neuroendocrine Tumor