Clinical trial • Phase II • Oncology|Endocrinology

EXENATIDE for Paraganglioma

Phase II trial of EXENATIDE for Paraganglioma. 10 participants.

Overview

Trial Therapeutic Area
Oncology|Endocrinology
Trial Disease
Paraganglioma
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme|Radiopharmaceutical
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
02-09-2024
First CTIS Authorization Date
27-09-2024

Trial design

Phase II trial in Netherlands.

Target Sample Size
10

Eligibility

Recruits 10 Vulnerable population not selected. Participants must be able to sign informed consent (inclusion: "Able to sign informed consent"; exclusion: "Not able to sign informed consent"). Children (<18 years) are excluded. Subject information and informed consent form documents (L1_SIS and ICF) are provided..

Pregnancy Exclusion
• Pregnancy or the wish to become pregnant within 1 month
Vulnerable Population
Vulnerable population not selected. Participants must be able to sign informed consent (inclusion: "Able to sign informed consent"; exclusion: "Not able to sign informed consent"). Children (<18 years) are excluded. Subject information and informed consent form documents (L1_SIS and ICF) are provided.

Inclusion criteria

  • {"criterion_text":"- •\tProven sympathetic PGL with a single tumor detected using standard diagnostic imaging"}
  • {"criterion_text":"- •\tNo evidence of metastatic disease"}
  • {"criterion_text":"- •\tCT and SSTR PET/CT performed (golden standard diagnostic imaging)"}
  • {"criterion_text":"- •\tScheduled for surgery"}
  • {"criterion_text":"- •\tAble to sign informed consent"}

Exclusion criteria

  • {"criterion_text":"- •\tBreast feeding"}
  • {"criterion_text":"- •\tPregnancy or the wish to become pregnant within 1 month"}
  • {"criterion_text":"- •\tCalculated creatinine clearance below 40ml/min"}
  • {"criterion_text":"- •\tEvidence of other malignancy than PGL in conventional imaging (suspicious liver, bone and lung lesions)"}
  • {"criterion_text":"- •\tAge < 18 years"}
  • {"criterion_text":"- •\tNot able to sign informed consent"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Detection rate of PGLs (paragangliomas) using 68Ga-exendin-4 PET/CT","definition_or_measurement_approach":"Not specified in provided data."}

Secondary endpoints

  • {"endpoint_text":"- optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT","definition_or_measurement_approach":"Not specified in provided data."}
  • {"endpoint_text":"- Comparison of quantitative imaging paramters (SUV, tumor-to-background ratio, contract-to-noise ratio) between Optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT, 18F-FDG PET and SSTR PET","definition_or_measurement_approach":"Semi-quantitative imaging parameters such as SUV, tumor-to-background ratio and contrast-to-noise ratio are to be compared between modalities (as stated). No further measurement detail provided."}
  • {"endpoint_text":"- correlation between GLP-1R expression and tracer uptake in the PGLs","definition_or_measurement_approach":"Not specified in provided data."}
  • {"endpoint_text":"- Correlation quantitative imaging results and IHC data to the genetic origin of the PGLs","definition_or_measurement_approach":"Not specified in provided data."}

Recruitment

Planned Sample Size
10
Recruitment Window Months
38
Consent Approach
Participants must be able to sign informed consent; exclusion of those not able to sign consent. Subject information and informed consent form documents (L1_SIS and ICF) are provided. No paediatric assent procedures described; children (<18) are excluded.

Geography

Total Number Of Sites
1
Total Number Of Participants
10

Netherlands

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
27-09-2024
Processing Time Days
8
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical imaging
Principal Investigator Name
Sevilay Tokgöz
Principal Investigator Email
sevilay.tokgoz@radboudumc.nl
Contact Person Name
Sevilay Tokgöz
Contact Person Email
sevilay.tokgoz@radboudumc.nl
Number Of Participants
10

Sponsor

Primary sponsor

Full Name
Stichting Radboud universitair medisch centrum
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
EXENATIDE
Active Substance
EXENATIDE
Modality
Peptide/protein/enzyme|Radiopharmaceutical
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Orphan Designation
Yes
Maximum Dose
100 MBq

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