Clinical trial · Interventional
HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
Typically, PET scans involve an IV injection of 18F-FDG that helps identify cancer. Patients are scanned 60 minutes after injecting 18F-FDG. This study aims to assess the feasibility of a different method of administration - oral ingestion (rather than IV) of 18F-FDG through delayed imaging to identify the optimal time for scanning after consuming the drug. The study will aim to recruit 15-24 individuals who will receive two PET scans - one using delayed oral 18F-FDG imaging and a second regular 18F-FDG. The analysis will focus on establishing a suitable protocol for this administration route while considering patient preference and image quality.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Feasibility Studies | — | UNRESOLVED | — |
| Multiple Cancers | — | UNRESOLVED | — |
| Multiple Indications Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral FDG scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral FDG scan and standard of care FDG scan
- description
- Participants will receive their standard of care FDG scan and then an Oral FDG scan within two weeks. The standard of care FDG scan will involve IV administration of FDG. The Oral FDG scan will involve FDG diluted in 50ml (approx.) of water to be consumed by mouth. The length of the oral FDG scans and its comparison to the standard FDG scan depends on which step the study is currently on. Please refer to the Study Design for details on the Oral FDG scan.
- interventionNames
- Diagnostic Test: Oral FDG scan
Primary outcomes (3)
- measure
- Number of hours for radiopharmaceutical to be cleared from stomach for optimal imaging
- timeFrame
- Periprocedural
- description
- To identify an acceptable imaging time to achieve gastric clearance of the radiopharmaceutical (time post administration in hours)
- measure
- Image quality compared to the standard of care FDG scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available