Neuroendocrine Tumors (NET)NCT05673031
68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors (NET), run by Alberta Health services at 1 site in Canada.
Trial summary
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] Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuroendocrine Tumors (NET)
- What is being tested?
- 68Ga-HA-DOTATATE PET/CT imaging
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Age greater than or equal to 18 years.
- Able and willing to follow instructions and comply with the protocol.
- Provide written informed consent prior to participation in the study.
- Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor
Who cannot join
- Nursing or pregnant females.
- Age less than 18 years.
- Surgery in the area of interest within the preceding 2 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Center 1403 29 St NW
Calgary, Alberta, T2N 2T9
Denise Chan, MD, 4039441252, denise.chan@albertahealthservices.ca
Kirstie Lithgow, MD, 403-388-6301, kclithgo@ucalgary.ca
About this study
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]
Read the 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.
- Conditions
- Neuroendocrine Tumors (NET)
- Being tested
- 68Ga-HA-DOTATATE PET/CT imaging
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HA-DOTATATE PET/CT imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-HA-DOTATATE | 68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE Receives: Diagnostic Test: 68Ga-HA-DOTATATE PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
68Ga-HA-DOTATATE PET/CT imaging
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Tumors (NET)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Denise Chan, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673031
- Sponsor's protocol ID
- NM-CRS-002
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT05673031
- Acronym / sponsor ID
- NM-CRS-002
- Conditions
- Neuroendocrine Tumors (NET)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-HA-DOTATATE | – | Diagnostic Test: 68Ga-HA-DOTATATE PET/CT imaging68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- Age greater than or equal to 18 years.
- Able and willing to follow instructions and comply with the protocol.
- Provide written informed consent prior to participation in the study.
- Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor
Key exclusion criteria (3 listed)
- Nursing or pregnant females.
- Age less than 18 years.
- Surgery in the area of interest within the preceding 2 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-HA-DOTATATE PET/CT imagingEach 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. | Diagnostic test | 68Ga-HA-DOTATATE |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors (NET), run by Alberta Health services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
68Ga-HA-DOTATATE PET/CT imaging (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.