A novel PET (positron emission tomography) tracer for donut-like PET findings in patients with neuroendocrine tumours

The role of [18F]FMISO PET in resolving Dotatate uptake in a doNUT-like pattern in neuroendocrine neoplasms

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001819213

Acronym

DONUT

Enrollment

Registered

2018-11-08

Start date

2018-10-31

Completion date

2021-04-16

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to examine the area around a neuroendocrine tumour using a scan called FMISO PET. Who is it for? You may be eligible for this study if you are aged 18 or over, and have a metastatic neuroendocrine tumour (NET). Study details All participants in this study will undergo one FMISO PET. The scan requires injection of a chemical called a tracer through a needle in the arm. The scan takes approximately 2 hours with the whole study visit on the day taking approximately 3 hours. It is hoped this research will help clinicians understand the biology of NET better, and help improve health outcomes in the long term as a result of this improved understanding.

Interventions

After signing consent, patients will be in the Nuclear Medicine department for approximately 3 hours. The intervention is a one-off injection of [18-F]-FMISO (dosage 300-350MBq), administered by the technologist. Imaging will be a mix of dynamic and static acquisitions from the time of injection to 120 minutes after injection. Standard PET machine settings will otherwise be used.

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Patients 18 years of age or older with metastatic neuroendocrine neoplasm (NEN) and histological confirmation who have undergone PET scans at Royal North Shore Hospital 2) Patients identified by the nuclear medicine physicians as having a lesion with 68Ga-DOTATATE PET (DOTA) avidity on the periphery but not the centre of the lesion (i.e. lack of avidity in the hole of the “donut“-like tumour).

Exclusion criteria

1) Patients who have not received a PET scan at RNSH 2) Patients without a histological diagnosis of metastatic NEN 3) Inability to lie in a supine position on the PET scanning bed for 15 minutes; 4) Subjects who required sedation for their baseline clinical PET scan; 5) Renal failure requiring haemo- or peritoneal dialysis; 6) Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the patient’s participation in the study or evaluation of the study results;

Outcome results