High-throughput long-axial PET using oral 18F-FDG
HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG
This study will test whether swallowing 18F-FDG and being scanned on a long-axial PET scanner can produce clear cancer images compared with the standard IV-injected PET in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07295171 on ClinicalTrials.gov |
What this trial studies
The study will recruit about 15–24 adults who have recently had a standard-of-care 18F-FDG PET/CT and are willing to undergo a second research scan. Each participant will receive two scans: a delayed imaging protocol after oral ingestion of 18F-FDG and a conventional IV 18F-FDG PET/CT, using a long-axial field-of-view Siemens Quadra scanner. Investigators will compare image quality, uptake timing, and patient preference to define an optimal oral-administration protocol. The work aims to leverage the Quadra's faster, higher-resolution imaging to see if oral dosing can be a feasible clinical alternative to IV injection.
Who should consider this trial
Good fit: Adults aged 19 and older with cancer who have recently had a standard 18F-FDG PET/CT and are willing to undergo an additional oral 18F-FDG PET/CT within two weeks are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, unable to swallow, have very high fasting blood glucose (>11.0 mmol/L), require enteral tubes or are immobile, incontinent, or cannot lie flat are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, oral 18F-FDG with a long-axial PET scanner could reduce the need for IV access, speed throughput, and improve patient comfort while maintaining diagnostic image quality.
How similar studies have performed: Small prior feasibility reports have explored oral 18F-FDG and delayed imaging, but combining oral dosing with long-axial field-of-view scanners is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥19 years * Participants who have received a standard of care \[18F\]FDG PET/CT and are willing to undergo a study specific oral \[18F\]FDG PET/CT within 2 weeks. Exclusion Criteria: Participant Inclusion Criteria * Age ≥19 years * Participants who have received a standard of care \[18F\]FDG PET/CT and are willing to undergo a study specific oral \[18F\]FDG PET/CT within 2 weeks. Participant Exclusion Criteria * Pregnant or breast-feeding * Medically unstable (e.g., acute illness, unstable vital signs) * Urinary incontinence/catheter. * Immobile, frail or vulnerable patients who cannot leave the department and would require an uptake room in any case. * Patients whose fasting blood sugar at the SOC PET was \>11.0 mmol/l * Unable to swallow. * Patients with nasogastric tubes, percutaneous gastrostomy or other non-anatomical routes for nutrition. * Unable to lie flat for 1h (subset of participants - first 5 participants only). * Claustrophobia requiring medication. * Undergoing active treatment or assessment of an upper digestive tract tumor (stomach/esophagus) * Unable to provide written consent * Patients receiving biguanide anti-hyperglycemic agents (e.g. Metformin). * Insulin dependent diabetics.
Where this trial is running
Vancouver, British Columbia
- BC Cancer Vancouver — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Pavithraa Administrative Research Manager
- Email: pavithraa.ravi@bccancer.bc.ca
- Phone: 6048776000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.