Neuroendocrine TumorsNCT04207762
18F-AmBF3-TATE PET/CT for Imaging NET Patients
An observational study of Neuroendocrine Tumors, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 18F-AmBF3-TATE PET/CT and Routine blood draw
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jun 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This will be a prospective, open-label trial in patients with proven/documented SSTR positive tumors.
Who may be able to join
- All subjects:
- Participants with newly diagnosed or documented neuroendocrine tumours (NET), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-FDG, 18F-FDOPA or 68Ga-DOTATOC/DOTATATE scan) or scintigraphy (with 111In-pentetreotide imaging).
- ECOG performance status of 2 or less.
Who cannot join
- Pregnancy
- Medically unstable (eg. acute illness, unstable vital signs)
- Unable to lie supine for the duration of imaging
- Unable to provide written consent
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
- Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes.
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- Patients with baseline ALT or AST higher than 5× ULN or 250 U/L.
- Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR >1.2, or platelet count below the lower limit of normal (typically <150 000/μL.
- Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Sensitivity of 18F-AmBF3-TATE PET/CT for Imaging NET Patients
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs.
This study proposes 18F-AmBF3-TATE positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the biodistribution and safety of 18F-AmBF3-TATE PET/CT for neuroendocrine tumour imaging.
Read the detailed description
Each subject will have a PET/CT scan using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.
After providing informed written consent subjects will complete a medical history questionnaire.
Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 18F-AmBF3-TATE . Eighteen to seventy-two hours after 18F-AmBF3-TATE administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire.
Follow-up Assessments
The following information will be collected up to 12 months following the PET/CT scans:
Initiation of a new treatment, Laboratory results and pathology reports, Results of imaging studies, Final clinical diagnosis by physician and relevant clinical notes. The study is expected to take up to 1 year for accrual.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 18F-AmBF3-TATE PET/CT, Routine blood draw
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AmBF3-TATE PET/CTDiagnostic test
Blood pressure, heart rate, and oxygen saturation levels and EKG monitoring (vital signs) will be recorded prior to the injection and at three other stages of the scan visit. Each study subject will have an intravenous catheter inserted. Prior to the radiotracer injection an ultra low dose CT will be taken. Subjects are positioned supine, arms down. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site. A Dynamic PET scan will be taken of the heart. Then a serial whole body PET scan will be done. Vital signs will be taken again and the subject will have a bathroom break. The patient will return to the scanner bed for a standard low dose CT and whole body PET scan. Vital signs will be taken again, and subject will be allowed to use the washroom again. The subject will return to the scanner bed for the final time for an ultra low dose CT and whole body PET scan. A final set of vitals will be taken and the subject will be discharged.
Routine blood drawDiagnostic test
Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after [18F]AmBF3-TATE administration.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT Diagnostic Imaging | Each subject will have a PET/CT scan, using 18F-AmBF3-TATE. 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. Receives: Diagnostic Test: 18F-AmBF3-TATE PET/CT; Diagnostic Test: Routine blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of 18F-AmBF3-TATE PET/CT in human subjects
Measurement of radiotracer uptake at multiple time points following radiotracer injection. Calculation of radiation dosimetry using OLINDA 2.0 methodology. Determination of tumour uptake in terms of standardized uptake values and tumour/blood, tumour/liver and tumour/lung ratios (descriptive analysis). For accuracy determination, it is anticipated that only a subset of participants may have a complete gold standard for the determination of accuracy. The sensitivity, specificity and accuracy (along with the confidence interval) of 18F-AMBF3-TATE will be calculated for patients with an available gold standard. The proportion of participants with a complete gold standard is not yet known for this study.
Measured: 1 year
Secondary outcomes (3)
Number of participants with 18F-AmBF3-TATE - related adverse events as assessed by abnormal vital sign measurement.
Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at four time points. All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.
Measured: Before injection, 1 hours post injection, 2 hours post injection and 2.5 hours post injection
Number of participants with self-reported 18F-AmBF3-TATE -related adverse event
Patients will return to the department 18-72 hours after the 18F-AmBF3-TATE PET/CT scan to see if they experienced any adverse events. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.
Measured: 18-72 hours
Total number of lesions per anatomic location identified by 18F-AmBF3-TATE PET/CT
All lesions will be tabulated and classified by compartment (pancreas, liver, bowel, lung and mediastinum, abdomen and retroperitoneal lymph nodes, bone, other) for all imaging that has been done for that subject. A total number of lesions will be calculated and a proportion of lesions detected will be reported and will be compared by calculating the median and its confidence interval. This will assess the biodistribution of 18F-AmBF3-TATE PET/CT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start9 Jun 2020
- Primary completion21 Sep 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207762
- Sponsor's protocol ID
- H19-03674
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Sensitivity of 18F-AmBF3-TATE PET/CT for Imaging NET Patients
- ClinicalTrials.gov ID
- NCT04207762
- Acronym / sponsor ID
- H19-03674
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 23 Dec 2019 (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.
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs.
This study proposes 18F-AmBF3-TATE positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the biodistribution and safety of 18F-AmBF3-TATE PET/CT for neuroendocrine tumour imaging.
Detailed description
Each subject will have a PET/CT scan using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.
After providing informed written consent subjects will complete a medical history questionnaire.
Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 18F-AmBF3-TATE . Eighteen to seventy-two hours after 18F-AmBF3-TATE administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire.
Follow-up Assessments
The following information will be collected up to 12 months following the PET/CT scans:
Initiation of a new treatment, Laboratory results and pathology reports, Results of imaging studies, Final clinical diagnosis by physician and relevant clinical notes. The study is expected to take up to 1 year for accrual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT Diagnostic Imaging | – | Diagnostic Test: 18F-AmBF3-TATE PET/CT, Diagnostic Test: Routine blood drawEach subject will have a PET/CT scan, using 18F-AmBF3-TATE. 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a prospective, open-label trial in patients with proven/documented SSTR positive tumors.
Key inclusion criteria (3 listed)
- Participants with newly diagnosed or documented neuroendocrine tumours (NET), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-FDG, 18F-FDOPA or 68Ga-DOTATOC/DOTATATE scan) or scintigraphy (with 111In-pentetreotide imaging).
- ECOG performance status of 2 or less.
Key exclusion criteria (9 listed)
- Pregnancy
- Medically unstable (eg. acute illness, unstable vital signs)
- Unable to lie supine for the duration of imaging
- Unable to provide written consent
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
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 |
|---|---|---|
| 18F-AmBF3-TATE PET/CTBlood pressure, heart rate, and oxygen saturation levels and EKG monitoring (vital signs) will be recorded prior to the injection and at three other stages of the scan visit. Each study subject will have an intravenous catheter inserted. Prior to the radiotracer injection an ultra low dose CT will be taken. Subjects are positioned supine, arms down. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site. A Dynamic PET scan will be taken of the heart. Then a serial whole body PET scan will be done. Vital signs will be taken again and the subject will have a bathroom break. The patient will return to the scanner bed for a standard low dose CT and whole body PET scan. Vital signs will be taken again, and subject will be allowed to use the washroom again. The subject will return to the scanner bed for the final time for an ultra low dose CT and whole body PET scan. A final set of vitals will be taken and the subject will be discharged. | Diagnostic test | PET/CT Diagnostic Imaging |
| Routine blood drawComplete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after [18F]AmBF3-TATE administration. | Diagnostic test | PET/CT Diagnostic Imaging |
Primary outcome
Biodistribution of 18F-AmBF3-TATE PET/CT in human subjects
Time frame: 1 year
Measurement of radiotracer uptake at multiple time points following radiotracer injection. Calculation of radiation dosimetry using OLINDA 2.0 methodology. Determination of tumour uptake in terms of standardized uptake values and tumour/blood, tumour/liver and tumour/lung ratios (descriptive analysis). For accuracy determination, it is anticipated that only a subset of participants may have a complete gold standard for the determination of accuracy. The sensitivity, specificity and accuracy (along with the confidence interval) of 18F-AMBF3-TATE will be calculated for patients with an available gold standard. The proportion of participants with a complete gold standard is not yet known for this study.
3 secondary outcomes
Number of participants with 18F-AmBF3-TATE - related adverse events as assessed by abnormal vital sign measurement.
Time frame: Before injection, 1 hours post injection, 2 hours post injection and 2.5 hours post injection
Number of participants with self-reported 18F-AmBF3-TATE -related adverse event
Time frame: 18-72 hours
Total number of lesions per anatomic location identified by 18F-AmBF3-TATE PET/CT
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by British Columbia Cancer Agency 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 20 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of 18F-AmBF3-TATE PET/CT in human subjects (time frame: 1 year). 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 20 Jan 2021.