HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG

NCT07295171 | Recruiting

• 1 other identifier: H25-02148
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Cancers; Multiple Indications Cancer; Feasibility Studies

Keywords

Oral FDG; LAFOV; Long-axial Field-of-view Scanner; Quadra; Low-dose Oral Radiopharmaceuticals

Outcome Measures

Primary Outcomes (3)

• Number of hours for radiopharmaceutical to be cleared from stomach for optimal imaging

  To identify an acceptable imaging time to achieve gastric clearance of the radiopharmaceutical (time post administration in hours)

  Periprocedural

• Image quality compared to the standard of care FDG scan

  They shall be asked to rate the quality of each scan on a five point Likert scale (5 being the highest, 1 being the lowest).

  within 2 weeks of the scan

• To assess participant preference for this method of administering radiopharmaceutical

  Participants will be given a sheet with 4 questions to answer about their experiences with the new mode of administration. The questions are: 1. Which scan did you prefer: oral or the injection? Why? 2. Where do you prefer to wait: in the uptake room or outside the department? Why? 3. What did you do during the waiting time for the study scan? (select all that apply) Walk / read/ listen to music / talk with friends/family / other (specify) 4. Did you drink water while waiting? How much \_\_ mL

  periprocedural

Study Arms (1)

Oral FDG scan and standard of care FDG scan

EXPERIMENTAL

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.

Diagnostic Test: Oral FDG scan

Interventions

Oral FDG scan DIAGNOSTIC_TEST

Evaluating the feasibility, scan quality and ease of administration when FDG is consumed orally rather than administered by IV.

Oral FDG scan and standard of care FDG scan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Central Study Contacts

Pavithraa Administrative Research Manager

CONTACT

6048776000; pavithraa.ravi@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step 1: N=5 Dosimetry (1h dynamic scan post ingestion of the radiopharmaceutical) and initial assessment of biodistribution at 2h Step 2: N=3 To determine if patients may leave the uptake room, move gently and consume water during the longer waiting period before the static scan. To determine if 3h post ingestion is sufficient. Step 2a: N=3-12 p.r.n. Interim step if further refinements to patient behavior or the uptake time is necessary. If not required, proceed to Step 3 Step 3: N=7 Assessment of final protocol

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: December 19, 2025
• Study Start: February 18, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 18, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)