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68Ga-DOTATATE Neuroblastoma Imaging Pilot

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: NCT04559217
Recruitment Status : Not yet recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Brief Summary:
Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: Radiopharmaceutical 68Ga-DOTATATE Phase 2

Detailed Description:

Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.

Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.

Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot

Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.

Study population: Children and adults with biopsy-proven or suspected neuroblastoma

Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective pilot study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : November 15, 2026
Estimated Study Completion Date : August 30, 2027


Arm Intervention/treatment
Experimental: Single arm with 68Ga-DOTATATE
all participants will undergo a PET scan with 68Ga-DOTATATE
Biological: Radiopharmaceutical 68Ga-DOTATATE
Injection of 68Ga-DOTATATE followed by PET/CT acquisition




Primary Outcome Measures :
  1. Accrual rate [ Time Frame: For the duration of the study, lasting 6 years ]
    Number of participants enrolled / year

  2. Rate of adverse events [ Time Frame: Up to 24 hours following injection of 68Ga-DOTATATE ]
    Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition


Secondary Outcome Measures :
  1. Positive lesions for 68Ga-DOTATATE [ Time Frame: One hour post-injection of 68Ga-DOTATATE ]
    SUV mean of the lesion

  2. Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG [ Time Frame: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan) ]
    the number of discordant lesions divided by the number of total positive lesions is the discordance rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected or biopsy-proven neuroblastoma
  • Planned 123I-MIBG imaging
  • Able and willing to provide signed informed consent in French or English (for the adult candidates or the parent/legal tutor of the pediatric candidates)

Exclusion Criteria:

  • History of another cancer in the past 5 years other than non-melanomatous skin cancer.
  • Currently under a randomized control trial with unknown allocation;
  • Medical/surgical intervention on the tumour between 123I-MIBG and 68Ga-DOTATATE PET/CT scan.
  • Medically unstable or unable to undergo scan.
  • Pregnancy (breastfeeding is not an exclusion criterion but needs to be stopped for at least 12 hours after 68Ga-DOTATATE injection).
  • Prior allergic reaction to somatostatin analogues

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): NCT04559217


Contacts
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Contact: Daphnee Lamarche, PhD 819-346-1110 ext 15571 daphnee.lamarche@usherbrooke.ca
Contact: Amelie Tetu, MSc 819-346-1110 ext 15571 amelie.tetu.ciussse-chus@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CIUSSS de L'Estrie-CHUS Hospital
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Daphnee Lamarche, PhD    819-346-1110 ext 15571    daphnee.lamarche@usherbrooke.ca   
Contact: Amelie Tetu, MSc    819-346-1110 ext 15571    amelie.tetu.ciussse-chus@ssss.gouv.qc.ca   
Principal Investigator: Etienne Rousseau, MD, FRCPC         
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Investigators
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Principal Investigator: Etienne Rousseau, MD, FRCPC CIUSSSE-CHUS
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Responsible Party: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT04559217    
Other Study ID Numbers: 2021-3828
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
imaging
68Ga-Dotatate
68Ga-Octreotate
positron emission tomography (PET)
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Neuroblastoma
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
Radiopharmaceuticals