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18F-FDOPA PET in Neuroendocrine Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02431715
Expanded Access Status : Available
First Posted : May 1, 2015
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency

Brief 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. 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.


Condition or disease Intervention/treatment
Thyroid Cancer, Medullary Carcinoid Tumor Pheochromocytoma Paraganglioma Insulinoma Neuroblastoma Drug: [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA)

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Study Type : Expanded Access
Official Title: [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) Positron Emission Tomography (PET) in Neuroendocrine Tumours



Intervention Details:
  • Drug: [18 F]-6-L-fluorodihydroxyphenylalanine (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.

    Other Name: 18F-FDOPA

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431715


Contacts
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Contact: Don C Wilson, MD 604-877-6000
Contact: Hayley Corbett

Locations
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Canada, British Columbia
BC Cancer Agency Available
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Don C Wilson, MD    604-877-6000      
Principal Investigator: Don C Wilson, MD         
Sub-Investigator: Francois Benard, MD         
Sub-Investigator: R. Petter Tonseth, MD         
Sub-Investigator: John Powe, MD         
Sub-Investigator: Daniel Worsley, MD         
Sub-Investigator: Helen Nadel, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02431715    
Other Study ID Numbers: H12-01795
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Neuroblastoma
Neuroendocrine Tumors
Carcinoid Tumor
Pheochromocytoma
Paraganglioma
Insulinoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Neoplasms by Site
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Adenoma, Islet Cell
Adenoma
Pancreatic Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action