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Not yet recruiting NCT07621146

A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies

— Observational Neuroendocrine Tumors, NET Pheochromocytoma/Paraganglioma SSTR-expressing Tumors Medullary Thyroid Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-DOTATATE PET/CT, 18F-AmBF3-TATE PET/CT.
Who it may be relevant to
Registry conditions: Neuroendocrine Tumors, NET, Pheochromocytoma/Paraganglioma, SSTR-expressing Tumors, Medullary Thyroid Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective and Head-to-head Comparison of [68Ga] Ga-DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies: NET-COMPARE Study

Overview

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 molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.

Interventions

  • Diagnostic test 68Ga-DOTATATE PET/CT
    Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the standard of care tracer 68Ga-DOTATATE from an approved study supplier site. The participant will rest in a comfortable chair for 60 minutes. After this uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supin
  • Diagnostic test 18F-AmBF3-TATE PET/CT
    Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the investigational tracer 18F-AmBF3-TATE from an approved study supplier site. The participant will rest in a comfortable chair for 60 minutes. After this uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supin

Primary outcome measures

  • Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE [Time frame: Periprocedural]
Secondary outcome measures (5)
  • Number of patients in whom one or more target lesions are detected by the core readers. [Time frame: within 2 weeks of the scan]
  • Standard Uptake Values (SUV) for lesions detected [Time frame: within 2 weeks of the scan]
  • CNR (contrast to noise ratio), TBR (tumor tissue to background tissue ratio), Tumor/blood; Tumor/Liver; Tumor/ kidney; tumor/lung, Likert scale for reader quality assessment [Time frame: within 2 weeks of the scan]
  • Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement [Time frame: within 2 weeks of the scan]
  • Frequency of adverse events (AE) and serious adverse events (SAE). [Time frame: Immediately post-scan]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Patients referred for and meeting institutional criteria for a \[68Ga\]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A).

Exclusion criteria

  • Pregnant and breast-feeding patients.
  • Patients unwilling or unable to undergo a second PET/CT.
  • Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • BC Cancer Vancouver — Vancouver

Identifiers

NCT: NCT07621146 · H26-00640

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗