Health TrialsbyHealthPanel

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

ConditionsMultiple CancersMultiple Indications CancerFeasibility Studies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorBritish Columbia Cancer Agency

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Oral FDG scan

    Diagnostic test

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

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Oral FDG scan and standard of care FDG scanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Periprocedural
2

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).

Time frame
within 2 weeks of the scan
3

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

Time frame
periprocedural

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

Source ClinicalTrials.gov
Apply now