68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors

January 4, 2023 updated by: Dr. Denise Chan, Alberta Health services
To determine if 68Ga-HA-DOTATATE PET/CT imaging is effective at diagnosing somatostatin positive tumors compared to conventional imaging [including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available]

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the current study will be to evaluate the usefulness of 68Ga-HA-DOTATATE compared to current standard anatomical imaging including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available. Specifically, we aim to assess the utility of 68Ga-HA-DOTATATE in primary workup of neuroendocrine tumours, including suspected neuroendocrine tumours that do not have a cross-sectional imaging correlate. An additional aim is to assess the role of 68Ga-HA-DOTATATE in surveillance of completely resected neuroendocrine tumours, which is a point of disagreement amongst current society guidelines . Finally, we will assess utility of 68Ga-HA-DOTATATE for localization of functioning neuroendocrine tumors including insulinoma and gastrinoma.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor. Patients greater than 18 years of age who are able to follow instructions and provide written consent to participate in study.

Description

Inclusion Criteria:

  1. Male or female. If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test will be required.
  2. Age greater than or equal to 18 years.
  3. Able and willing to follow instructions and comply with the protocol.
  4. Provide written informed consent prior to participation in the study.
  5. Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor

Exclusion Criteria:

  1. Nursing or pregnant females.
  2. Age less than 18 years.
  3. Surgery in the area of interest within the preceding 2 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
68Ga-HA-DOTATATE
68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE
Diagnostic test: 68Ga-HA-DOTATATE PET/CT imaging

Each patient will receive an IV injection 68Ga-HA-DOTATATE. Imaging will be conducted beginning 45-90 minutes after an injection of between 100-250 MBq 68Ga-HA-DOTATATE in patients.

  • After the 68Ga-HA-DOTATATE acquisition is complete, a CT scan will be performed for attenuation correction and localization in the same in line gantry without patient movement between the two scans.
  • The results of the 68Ga-HA-DOTATATE PET/CT will be compared to any prior imaging and pathologic results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
68Ga-HA-DOTATATE PET/CT imaging
Time Frame: 5 years
To compare 68Ga-HA-DOTATATE PET/CT imaging at identifying somatostatin positive tumors to conventional imaging [including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available]. 68Ga-HA-DOTATATE PET/CT scans will be evaluated for abnormal accumulation of 68Ga-HA-DOTATATE. Any abnormal uptake will be determined for up to 5 lesions and compared to results of standard of care imaging performed [including CT, MRI, 111 In-pentetreotide (OctreoscanTM) Scan with SPECT/CT, 18F-FDG PET/CT, as available] for presence/absence of each lesion. Comparison to any follow up 68Ga-HA-DOTATATE PET/CT Scans will also be performed (up to 5 follow up68Ga-HA-DOTATATE PET/CT Scans will be allowed).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

January 1, 2027

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-CRS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroendocrine Tumors (NET)

Clinical Trials on 68Ga-HA-DOTATATE PET/CT imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe