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68Ga-DOTA-TATE PET/CT Imaging in NETs

Primary Purpose

Neuroendocrine Tumors

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
68Ga-DOTA-TATE
Sponsored by
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring 68Ga-DOTA-TATE, PET imaging, Pragmatic study, Neuroendocrine tumors (NET)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor
  2. Patients with suspected or proven tumors expressing somatostatin receptors
  3. Informed consent by patient (or parents if patient is less than 18 years of age)

Exclusion Criteria:

  1. *Pregnancy (not an absolute exclusion). See below*.
  2. Patient refusal to participate.

  3. Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.

    • In the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient. In this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. The conditions to decide whether to include the patient would be:

      • Severe medical condition involving the life of the pregnant woman and/or the fetus;
      • Existing treatments that are ineffective or may present toxicity to the woman and/or fetus;
      • High clinical suspicion of a somatostatin receptor overexpressing tumour;
      • Negative, indeterminate or contraindicated first-line imaging tests;
      • Therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery;
      • Documented discussion with the treating team and the patient;
      • Patient agrees.

Sites / Locations

  • CHUSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuroendocrine cancer patients

Arm Description

All neuroendocrine cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.

Outcomes

Primary Outcome Measures

Safety profile of 68Ga-DOTA-TATE
Following the injection, the patient will be explicitly reminded of possible symptoms and undesirable events. The patient will be advised to inform the study personnel of the occurrence of any events, at the most opportune time. The patient will be instructed to call the local nuclear medicine study coordinator for any undesirable event that may occur for 48 hours after the PET/CT scan. Safety will be assessed by compiling all reported adverse events. Adverse events reported by patients or observed by the investigator will be recorded in the patients' CRFs, the AE database, and reported to the research manager.

Secondary Outcome Measures

Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management
Neuroendocrine tumors (NET) used to be difficult to diagnose early with conventional methods, but with the advent of new-generation Somatostatin Receptor radioligands such as 68Ga-DOTA-TATE precise and early detection is now frequent. This trial offers the opportunity to evaluate the impact of this state-of-the-art diagnostic procedure on the management of NET patients on a large, nation-wide cohort. As such, the research team will monitor the clinical gain of 68Ga-DOTA-TATE on the diagnostic and management of NETs regarding sensitivity, specificity and accuracy compared to previous diagnostic methods.
Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients
Clinical and scientific evidences showed that 68Ga-DOTA-TATE is vastly superior as a diagnostic tool than the current standard-of-care Octreoscan. As such, this trial aims to implement 68Ga-DOTA-TATE as the new standard-of-care for precision diagnostic of NETs. In order to do so, health policy agencies (most notably Health Canada) will be notified about the gains (or the flaws if any) of 68Ga-DOTA-TATE over the current standard-of-care (Octreoscan) for the precise diagnostic and follow-up of NETs that will be observed during the present study. The safety profile and diagnostic accuracy assessed in Outcome 1 and 2 will be used to convince the authorities of the net benefit of using this procedure rather than the "old" standard-of-care.

Full Information

First Posted
April 8, 2021
Last Updated
July 18, 2022
Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT04847505
Brief Title
68Ga-DOTA-TATE PET/CT Imaging in NETs
Official Title
Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the PET radiotracer 68Ga-DOTA-TATE, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. It is a single-center study, but with recruitment across all Canada. The trial is prospective, non-randomized, open-label and with no control group. The superiority of this procedure over the former standard-of-care (Octreoscan) was already established in previous and numerous studies across the world. As such, the current trial aims to gather data to further support the implementation of 68Ga-DOTA-TATE as the new standard-of-care for neuro-endocrine tumors (NET).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
68Ga-DOTA-TATE, PET imaging, Pragmatic study, Neuroendocrine tumors (NET)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Neuroendocrine cancer patients, regardless of the primary tumor origin, are eligible. Recruitment is across all Canada but the examination is performed at the primary site of the study. The safety profile of the procedure will be assessed, and integration of 68Ga-DOTA-TATE will be integrated in the routine clinical practice.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuroendocrine cancer patients
Arm Type
Experimental
Arm Description
All neuroendocrine cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-DOTA-TATE
Other Intervention Name(s)
Netspot
Intervention Description
The intervention consists of an intravenous injection of the radiopharmaceutical 68Ga-DOTA-TATE and a physiological saline flush, followed 45-90 minutes later by a PET/CT image acquisition.
Primary Outcome Measure Information:
Title
Safety profile of 68Ga-DOTA-TATE
Description
Following the injection, the patient will be explicitly reminded of possible symptoms and undesirable events. The patient will be advised to inform the study personnel of the occurrence of any events, at the most opportune time. The patient will be instructed to call the local nuclear medicine study coordinator for any undesirable event that may occur for 48 hours after the PET/CT scan. Safety will be assessed by compiling all reported adverse events. Adverse events reported by patients or observed by the investigator will be recorded in the patients' CRFs, the AE database, and reported to the research manager.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management
Description
Neuroendocrine tumors (NET) used to be difficult to diagnose early with conventional methods, but with the advent of new-generation Somatostatin Receptor radioligands such as 68Ga-DOTA-TATE precise and early detection is now frequent. This trial offers the opportunity to evaluate the impact of this state-of-the-art diagnostic procedure on the management of NET patients on a large, nation-wide cohort. As such, the research team will monitor the clinical gain of 68Ga-DOTA-TATE on the diagnostic and management of NETs regarding sensitivity, specificity and accuracy compared to previous diagnostic methods.
Time Frame
5 years
Title
Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients
Description
Clinical and scientific evidences showed that 68Ga-DOTA-TATE is vastly superior as a diagnostic tool than the current standard-of-care Octreoscan. As such, this trial aims to implement 68Ga-DOTA-TATE as the new standard-of-care for precision diagnostic of NETs. In order to do so, health policy agencies (most notably Health Canada) will be notified about the gains (or the flaws if any) of 68Ga-DOTA-TATE over the current standard-of-care (Octreoscan) for the precise diagnostic and follow-up of NETs that will be observed during the present study. The safety profile and diagnostic accuracy assessed in Outcome 1 and 2 will be used to convince the authorities of the net benefit of using this procedure rather than the "old" standard-of-care.
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor Patients with suspected or proven tumors expressing somatostatin receptors Informed consent by patient (or parents if patient is less than 18 years of age) Exclusion Criteria: *Pregnancy (not an absolute exclusion). See below*. Patient refusal to participate. Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs. In the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient. In this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. The conditions to decide whether to include the patient would be: Severe medical condition involving the life of the pregnant woman and/or the fetus; Existing treatments that are ineffective or may present toxicity to the woman and/or fetus; High clinical suspicion of a somatostatin receptor overexpressing tumour; Negative, indeterminate or contraindicated first-line imaging tests; Therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery; Documented discussion with the treating team and the patient; Patient agrees.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Dubreuil
Phone
819-346-1110
Ext
16617
Email
Stephanie.Dubreuil2@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Éric E Turcotte, MD
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Dubreuil
Phone
819-346-1110
Ext
16617
Email
Stephanie.Dubreuil2@Usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Éric Turcotte, MD

12. IPD Sharing Statement

Learn more about this trial

68Ga-DOTA-TATE PET/CT Imaging in NETs

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