Thyroid Cancer, MedullaryNCT02431715
18F-FDOPA PET in Neuroendocrine Tumours
A study testing [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) in people with Thyroid Cancer, Medullary and Carcinoid Tumor, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the gastroenteropancreatic tract. They are usually slow growing, have low malignant potential, and often go unnoticed until they become metastatic. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Thyroid Cancer, Medullary, Carcinoid Tumor, Pheochromocytoma
- What is being tested?
- [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 1 month and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients who meet the BCCA approved clinical indications for 18F-FDOPA PET/CT scans in neuroendocrine tumours.
- ECOG performance status 0 - 3.
- Able to provide written informed consent (or consent by guardian for subjects <19 years).
- Referred by a treating BC physician.
- Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 40 minutes and tolerating intravenous cannulation for injection.
Who cannot join
- Pregnancy.
- Patients who are medically unstable eg. acute cardiac or respiratory distress, hypotensive
- Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70 cm).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) Positron Emission Tomography (PET) in Neuroendocrine Tumours
Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the gastroenteropancreatic tract. They are usually slow growing, have low malignant potential, and often go unnoticed until they become metastatic. The correct treatment approach is dependent on the extent of the disease, however surgical approaches and systemic therapy can be curative.
Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer 18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising non-invasive technique to help localizing NETs and guide their treatment.
Read the detailed description
Purpose/Objective:
The purpose of this study is to provide access to 18F-6-L fluorodihydroxyphenylalanine (18F-FDOPA) positron emission tomography and computed tomography (PET/CT) imaging to patients with neuroendocrine tumours (NET) and to collect additional data about the effectiveness of 18F-DOPA PET/CT in this patient population.
Hypothesis:
- The overall accuracy of 18F-FDOPA PET/CT is superior to conventional imaging techniques for the detection of neuroendocrine tumours.
- The sensitivity of 18F-FDOPA PET/CT is superior to conventional imaging techniques for the detection of neuroendocrine tumours.
Justification:
Treatment of NET's depends on the extent of disease and rate of tumour progression. Accurate staging is critical to establish the prognosis of the disease, to guide potentially curative surgical approaches and to assist in therapeutic decision making between surgery, embolization techniques and systemic therapy. Standard radiologic and nuclear medicine techniques all have significant limitations in terms of their ability to detect these lesions and to evaluate response to treatment. The widely used PET tracer 18F-Fluorodeoxyglucose (18-FDG) is of limited value in NET's due to its non-specific uptake and the relatively low mitotic rate often seen in these tumours.
Combined PET/CTutilizing 18F-FDOPA has been investigated as a potentially sensitive and specific staging and localization technique for NETs. Expression of tumour-specific catecholamine transport and storage mechanisms by NET cells is the basis of 18F-DOPA PET imaging. Cellular uptake and radiopharmaceutical concentration in intracellular storage granules within tumour cells of neuroendocrine origin and differentiation, combined with the high sensitivity, resolution and accurate anatomic localization of PET/CT imaging, makes 18F-DOPA PET/CT potentially superior to standard nuclear medicine and radiologic techniques for the detection and localization of functioning and non-functioning NETs. This imaging technique not only provides specific functional and biochemical information via PET images, but also morphological and anatomical detail via CT images leading to more accurate localization and characterization on individual lesions. This may allow better treatment planning as well as restaging during and after therapy to assess disease response. The information retrieved from the hybrid 18F-FDOPA PET/CT could have a profound influence on diagnosis and treatment of patients with NETs.
Research Method:
This will be an expanded access study in which adult and pediatric subjects will be invited to participate. All subjects are informed of anticipated effects (none) and purpose of the injected substance. Subjects are approached by their treating physicians with respect to their willingness to participate in the proposed study based on clinical criteria. They will then undergo a brief clinical assessment followed by the PET/CT scanning protocol.
The BC Cancer Agency anticipates a start date in August 2012 and a potential completion date August of 2017. Three full years of data collection will provide meaningful numbers for analysis. A total of 300 patients, including adults and pediatric patients, will be recruited for the study. This number is based on the anticipated number of PET scan referrals expected over a five-year study timeframe.
Statistical Analysis:
The primary outcomes will be estimates of sensitivity, specificity and accuracy of 18F-DOPA PET. 95% confidence intervals will be calculated for all estimates. Outcomes will be estimated for the whole study population and for different types of cancer.
Sensitivity (ratio of true positive lesions to total positive lesions), specificity (ratio of true negative lesions to total negative lesions) and accuracy (ratio of total correct studies to the total number of biopsied lesions) of 18F-FDOPA PET studies performed by the BCCA will be obtained by comparing results of the PET scan with the gold-standard of histopathological diagnosis when those results are available (as determined by clinical indication and feasibility by the treating physician) and results of conventional imaging. Biopsy of lesions is not mandated by this study. Confidence intervals (95% CI) for sensitivity, specificity and accuracy will be calculated using exact binomial distribution.
Results will be compared to figures in the published literature. All analyses will be performed in direct consultation with a statistician who is a member of the BC Cancer Agency staff.
- Conditions
- Thyroid Cancer, Medullary, Carcinoid Tumor, Pheochromocytoma, Paraganglioma, Insulinoma, Neuroblastoma
- Being tested
- [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA)
- Medical subject headings
- Thyroid cancer, medullary, Carcinoid Tumor, Pheochromocytoma, Paraganglioma, Insulinoma, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA)Drug
Also called 18F-FDOPA
All patients will have their weight and baseline vital signs recorded.
The study subject will have an intravenous catheter inserted and receive a slow bolus intravenous dose of 185 - 370 MBq (5 -10mCi) 18F-FDOPA.
The patient will rest in a comfortable reclining chair in a warm, private shielded room for 45 to 60 minutes.
Patients are positioned supine and centered on the scanner bed for an average total scan time (CT and PET) of approximately 30 minutes.
Images will be interpreted by qualified and experienced physicians. Findings of significance from the PET/CT scan, and any incidental findings of significance from the CT scan, will be included in the single final report that will be issued to referring physicians.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Cancer, MedullaryStudies 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
- Expanded access
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
- NCT02431715
- Sponsor's protocol ID
- H12-01795
- Status last verified
- Nov 2022
- First submitted
- 27 Apr 2015
- Last updated
- 21 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) Positron Emission Tomography (PET) in Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT02431715
- Acronym / sponsor ID
- H12-01795
- Conditions
- Thyroid Cancer, Medullary, Carcinoid Tumor, Pheochromocytoma, Paraganglioma, Insulinoma, Neuroblastoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- First posted
- 1 May 2015 (estimated)
- 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 a group of neoplasms generally arising from the gastroenteropancreatic tract. They are usually slow growing, have low malignant potential, and often go unnoticed until they become metastatic. The correct treatment approach is dependent on the extent of the disease, however surgical approaches and systemic therapy can be curative.
Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer 18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising non-invasive technique to help localizing NETs and guide their treatment.
Detailed description
Purpose/Objective:
The purpose of this study is to provide access to 18F-6-L fluorodihydroxyphenylalanine (18F-FDOPA) positron emission tomography and computed tomography (PET/CT) imaging to patients with neuroendocrine tumours (NET) and to collect additional data about the effectiveness of 18F-DOPA PET/CT in this patient population.
Hypothesis:
- The overall accuracy of 18F-FDOPA PET/CT is superior to conventional imaging techniques for the detection of neuroendocrine tumours.
- The sensitivity of 18F-FDOPA PET/CT is superior to conventional imaging techniques for the detection of neuroendocrine tumours.
Justification:
Treatment of NET's depends on the extent of disease and rate of tumour progression. Accurate staging is critical to establish the prognosis of the disease, to guide potentially curative surgical approaches and to assist in therapeutic decision making between surgery, embolization techniques and systemic therapy. Standard radiologic and nuclear medicine techniques all have significant limitations in terms of their ability to detect these lesions and to evaluate response to treatment. The widely used PET tracer 18F-Fluorodeoxyglucose (18-FDG) is of limited value in NET's due to its non-specific uptake and the relatively low mitotic rate often seen in these tumours.
Combined PET/CTutilizing 18F-FDOPA has been investigated as a potentially sensitive and specific staging and localization technique for NETs. Expression of tumour-specific catecholamine transport and storage mechanisms by NET cells is the basis of 18F-DOPA PET imaging. Cellular uptake and radiopharmaceutical concentration in intracellular storage granules within tumour cells of neuroendocrine origin and differentiation, combined with the high sensitivity, resolution and accurate anatomic localization of PET/CT imaging, makes 18F-DOPA PET/CT potentially superior to standard nuclear medicine and radiologic techniques for the detection and localization of functioning and non-functioning NETs. This imaging technique not only provides specific functional and biochemical information via PET images, but also morphological and anatomical detail via CT images leading to more accurate localization and characterization on individual lesions. This may allow better treatment planning as well as restaging during and after therapy to assess disease response. The information retrieved from the hybrid 18F-FDOPA PET/CT could have a profound influence on diagnosis and treatment of patients with NETs.
Research Method:
This will be an expanded access study in which adult and pediatric subjects will be invited to participate. All subjects are informed of anticipated effects (none) and purpose of the injected substance. Subjects are approached by their treating physicians with respect to their willingness to participate in the proposed study based on clinical criteria. They will then undergo a brief clinical assessment followed by the PET/CT scanning protocol.
The BC Cancer Agency anticipates a start date in August 2012 and a potential completion date August of 2017. Three full years of data collection will provide meaningful numbers for analysis. A total of 300 patients, including adults and pediatric patients, will be recruited for the study. This number is based on the anticipated number of PET scan referrals expected over a five-year study timeframe.
Statistical Analysis:
The primary outcomes will be estimates of sensitivity, specificity and accuracy of 18F-DOPA PET. 95% confidence intervals will be calculated for all estimates. Outcomes will be estimated for the whole study population and for different types of cancer.
Sensitivity (ratio of true positive lesions to total positive lesions), specificity (ratio of true negative lesions to total negative lesions) and accuracy (ratio of total correct studies to the total number of biopsied lesions) of 18F-FDOPA PET studies performed by the BCCA will be obtained by comparing results of the PET scan with the gold-standard of histopathological diagnosis when those results are available (as determined by clinical indication and feasibility by the treating physician) and results of conventional imaging. Biopsy of lesions is not mandated by this study. Confidence intervals (95% CI) for sensitivity, specificity and accuracy will be calculated using exact binomial distribution.
Results will be compared to figures in the published literature. All analyses will be performed in direct consultation with a statistician who is a member of the BC Cancer Agency staff.
Study design
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the BCCA approved clinical indications for 18F-FDOPA PET/CT scans in neuroendocrine tumours.
- ECOG performance status 0 - 3.
- Able to provide written informed consent (or consent by guardian for subjects <19 years).
- Referred by a treating BC physician.
- Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 40 minutes and tolerating intravenous cannulation for injection.
Key exclusion criteria (3 listed)
- Pregnancy.
- Patients who are medically unstable eg. acute cardiac or respiratory distress, hypotensive
- Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot 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 |
|---|---|---|
| [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA)Also: 18F-FDOPAAll patients will have their weight and baseline vital signs recorded. The study subject will have an intravenous catheter inserted and receive a slow bolus intravenous dose of 185 - 370 MBq (5 -10mCi) 18F-FDOPA. The patient will rest in a comfortable reclining chair in a warm, private shielded room for 45 to 60 minutes. Patients are positioned supine and centered on the scanner bed for an average total scan time (CT and PET) of approximately 30 minutes. Images will be interpreted by qualified and experienced physicians. Findings of significance from the PET/CT scan, and any incidental findings of significance from the CT scan, will be included in the single final report that will be issued to referring physicians. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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?
A study testing [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) in people with Thyroid Cancer, Medullary and Carcinoid Tumor, 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 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: status not confirmed, as of the sponsor's last update on 21 Feb 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?
Results are not available in the source record.
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.
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 21 Feb 2023.