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PET/CT Scans for Neuroendocrine Cancer

Phase 2
Recruiting
Led By Jonathan Abele
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater or equal to 40
At least two abnormal 68Ga-HA-DOTATATE positive lesions suspected to represent neuroendocrine tumor (at least two lesions with SUVmax > SUV mean liver)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after completion of the 68ga-ha-dotatate, 18f-fdg, and investigational 18f-dopa pet/ct scans
Awards & highlights

Study Summary

This trial is testing three different ways to detect neuroendocrine tumors, to see which is most effective.

Who is the study for?
This trial is for adults aged 40 or older with a confirmed diagnosis of neuroendocrine tumors, including various types such as gastrointestinal, pancreatic, pulmonary NETs and others. Participants must have at least two abnormal lesions that are positive on a specific PET/CT scan. It's not suitable for those over 225 kg, with serious illnesses affecting the study outcome, previous allergic reactions to the imaging drug used in the trial (18F-DOPA), pregnant or breastfeeding women, or those unable to undergo scans.Check my eligibility
What is being tested?
The study compares three different PET/CT imaging agents—68Ga-HA-DOTATATE, 18F-DOPA with furosemide, and 18F-FDG—to see which one better detects metastatic neuroendocrine tumors on a lesion-by-lesion basis. The goal is also to understand if differences in tumor detection correlate with disease progression.See study design
What are the potential side effects?
Potential side effects from the interventions may include allergic reactions to the imaging drugs used during PET/CT scans. However, detailed side effect profiles are not provided; participants should discuss possible risks with their physician.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 years old or older.
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I have at least two lesions suspected to be a neuroendocrine tumor.
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I have a confirmed diagnosis of a neuroendocrine tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year after completion of both 18f-dopa and 18f-fdg pet/ct scans
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year after completion of both 18f-dopa and 18f-fdg pet/ct scans for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans
Secondary outcome measures
Assessment of disease progression - 12 months
Assessment of disease progression - 18 months
SUV of lesions on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-DOPA PET/CT scanExperimental Treatment1 Intervention
4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
884 Previous Clinical Trials
393,010 Total Patients Enrolled
3 Trials studying Neuroendocrine Tumors
1,800 Patients Enrolled for Neuroendocrine Tumors
Jonathan AbelePrincipal InvestigatorUniversity of Alberta

Media Library

18F-DOPA with furosemide Clinical Trial Eligibility Overview. Trial Name: NCT05255159 — Phase 2
Neuroendocrine Tumors Research Study Groups: 18F-DOPA PET/CT scan
Neuroendocrine Tumors Clinical Trial 2023: 18F-DOPA with furosemide Highlights & Side Effects. Trial Name: NCT05255159 — Phase 2
18F-DOPA with furosemide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05255159 — 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 recruitment phase of this research still open?

"Right, the latest information from clinicaltrials.gov confirms that this experiment is currently searching for participants to join. It was first advertised on October 15th 2022 and was recently modified on November 16th 2022. This trial seeks 50 patients at a single facility."

Answered by AI

What potential risks could arise from administering 18F-DOPA with furosemide to individuals?

"After carefully evaluating the Phase 2 trial data, our team at Power determined that 18F-DOPA with furosemide is safe and gave it a rating of 2."

Answered by AI

How many volunteers are involved in this medical experiment?

"Affirmative. The clinical trial information displayed on clinicaltrials.gov confirms that this medical study, which was initially posted on October 15th 2022, is actively recruiting patients. Around 50 individuals need to be enlisted from a single centre."

Answered by AI
~16 spots leftby Dec 2024