Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07621146

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Neuroendocrine Tumors, NET Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Medullary Thyroid Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma Pheochromocytoma Pheochromocytoma/Paraganglioma SSTR-expressing Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location contact

Pavithraa Ravi

CONTACT

[email protected]

6048776000 ext. 2818

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

68Ga-DOTATATE PET/CT

Diagnostic Test

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 supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.

18F-AmBF3-TATE PET/CT

Diagnostic Test

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 supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.

Primary outcomes

  1. Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE

    Time frame: Periprocedural

    To assess the non-inferiority of [18F]AmBF3TATE compared to the standard-of-care [68Ga]DOTATATE

Secondary outcomes

  1. Number of patients in whom one or more target lesions are detected by the core readers.

    Time frame: within 2 weeks of the scan

    Number of patients in whom [18F]AmBF3TATE and [68Ga]DOTATATE detects disease.

  2. Standard Uptake Values (SUV) for lesions detected

    Time frame: within 2 weeks of the scan

    To assess uptake values (SUV) for tumour lesions (SUVmax, SUVpeak, tumour to background ratio for liver, blood, kidney and lung, contrast and signal to noise ratio).

  3. 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

    To assess image quality using semi-quantitative (contrast-to-noise and tumour-to-background) and subjective indices

  4. 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

    To assess reader confidence and inter-rater agreement

  5. Frequency of adverse events (AE) and serious adverse events (SAE).

    Time frame: Immediately post-scan

    To compare the safety of both tracers

Study contacts

Contact information is provided by the study sponsor or research team.

Administrative Research Manager

CONTACT

[email protected]

604-877-6000 ext. 2818

Research Project Manager

CONTACT

[email protected]

604-675-8000 ext. 7649

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study 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

Acronym: NET-COMPARE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.