Multiple CancersHELPNCT07295171
HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG
A study testing Oral FDG scan in people with Multiple Cancers and Multiple Indications Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Cancers, Multiple Indications Cancer, Feasibility Studies
- What is being tested?
- Oral FDG scan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2026to 25 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Purpose:
Radiopharmaceutical:
18F-FDG is the most commonly PET radiopharmaceutical because of it's wide availability and its use across oncological indications. This tracer binds to the glucose molecules in the body to outline tumor cells. Typically it is administered through IV but this study will explore its feasibility when consumed orally.
Marketed device:
BC Cancer has recently acquired a Long Axis Field of View (LAFOV) machine (called Siemens Quadra) that can scan patients in 1-2 minutes rather than 20 minutes on a more commonly found SAFOV scanner. LAFOV scanners can provide much higher resolutions of scans compared to SAFOV.
The purpose of this study is to create an optimal protocol to scan patients with oral 18F-FDG on the LAFOV machine to utilize this machine's high resolution and fast throughput. From previous studies, investigators know that oral 18F-FDG is absorbed differently when compared to 18F-FDG through IV (Srinivas et al, 2020). To better inform the protocol, this study will use a delayed imaging method to assess the absorption during uptake time and image quality resulting from this different route of administration. Lastly, the study will compare scan results from oral 18F-FDG scans with that of regular 18F-FDG scans to assess the benefits and feasibility in a clinic setting.
Justification:
PET scans typically involve the injection of 18F-FDG through IV 60 minutes before the patient is scanned. The radiopharmaceutical is absorbed by the body during the uptake time of 60 minutes and the images resulting from the scan can be used to identify cancerous cells. This process requires the patient to be resting during uptake period to ensure the tracer isn't absorbed into muscles due to activity. Additionally, venous access could result in extravasation, bruises at injection site, patient discomfort and longer prep time for staff. In a clinic setting with higher throughput demands, number of uptake rooms and prep time are often the rate-limiting factor.
Consuming 18F-FDG orally results in a much slower uptake process (Srinivasan et al, 2020) and may eliminate the need to confine patients to a room during uptake. The LAFOV scanner is capable of scanning more patients in a period of time than uptake rooms are available. Therefore, not requiring patients to remain in a room may allow more patients to be scanned faster.
Research Design:
This study is a prospective, open-label, single-cohort, phase I study to determine the feasibility of scanning with oral FDG. Participation will involve one scan with regular FDG and one scan with oral FDG within 14 days of each other. The study will be divided into 3 steps to test different uptake times and patient activity levels for protocol optimization. Participants cannot participate in more than 1 step.
This small pilot study aims to determine the optimal examination protocol and feasibility of ambulatory and oral application of [18F]FDG in conjunction with a latest-generation high-sensitivity LAFOV scanner system. Comparisons between the oral and SOC intravenous scans will be made using descriptive statistics.
Sample size estimate:
The sample size for study will be a pragmatic determination based on feasibility considerations. So as not to unduly burden the study with the long 1h dosimetry requirements from kinetic scanning, the investigators shall perform dosimetry in 5 subjects.
The sample size is designed to afford a preliminary check of the protocol's feasibility before moving to the next stage. Once the final protocol is reached (Step 3) - a minimum of N=10 patients will be available with a comparable protocol for an initial estimate of the technique's performance.
The data generated will afford a power calculation for a phase II trial if appropriate STEP 1: N=5 STEP 2: N=3 STEP 2(a): N=3 (optional) STEP 3: N=7
- Being tested
- Oral FDG scan
- Keywords
- Oral FDG, LAFOV, Long-axial Field-of-view Scanner, Quadra, Low-dose Oral Radiopharmaceuticals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral FDG scanDiagnostic test
Evaluating the feasibility, scan quality and ease of administration when FDG is consumed orally rather than administered by IV.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Oral FDG scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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:
- Which scan did you prefer: oral or the injection? Why?
- Where do you prefer to wait: in the uptake room or outside the department? Why?
- 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)
- Did you drink water while waiting? How much __ mL
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start10 Feb 2026
- Primary completion25 Aug 2026
- Study completion25 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295171
- Sponsor's protocol ID
- H25-02148
- Acronym
- HELP
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG
- ClinicalTrials.gov ID
- NCT07295171
- Acronym / sponsor ID
- HELP / H25-02148
- Keywords
- Oral FDG, LAFOV, Long-axial Field-of-view Scanner, Quadra, Low-dose Oral Radiopharmaceuticals
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
Radiopharmaceutical:
18F-FDG is the most commonly PET radiopharmaceutical because of it's wide availability and its use across oncological indications. This tracer binds to the glucose molecules in the body to outline tumor cells. Typically it is administered through IV but this study will explore its feasibility when consumed orally.
Marketed device:
BC Cancer has recently acquired a Long Axis Field of View (LAFOV) machine (called Siemens Quadra) that can scan patients in 1-2 minutes rather than 20 minutes on a more commonly found SAFOV scanner. LAFOV scanners can provide much higher resolutions of scans compared to SAFOV.
The purpose of this study is to create an optimal protocol to scan patients with oral 18F-FDG on the LAFOV machine to utilize this machine's high resolution and fast throughput. From previous studies, investigators know that oral 18F-FDG is absorbed differently when compared to 18F-FDG through IV (Srinivas et al, 2020). To better inform the protocol, this study will use a delayed imaging method to assess the absorption during uptake time and image quality resulting from this different route of administration. Lastly, the study will compare scan results from oral 18F-FDG scans with that of regular 18F-FDG scans to assess the benefits and feasibility in a clinic setting.
Justification:
PET scans typically involve the injection of 18F-FDG through IV 60 minutes before the patient is scanned. The radiopharmaceutical is absorbed by the body during the uptake time of 60 minutes and the images resulting from the scan can be used to identify cancerous cells. This process requires the patient to be resting during uptake period to ensure the tracer isn't absorbed into muscles due to activity. Additionally, venous access could result in extravasation, bruises at injection site, patient discomfort and longer prep time for staff. In a clinic setting with higher throughput demands, number of uptake rooms and prep time are often the rate-limiting factor.
Consuming 18F-FDG orally results in a much slower uptake process (Srinivasan et al, 2020) and may eliminate the need to confine patients to a room during uptake. The LAFOV scanner is capable of scanning more patients in a period of time than uptake rooms are available. Therefore, not requiring patients to remain in a room may allow more patients to be scanned faster.
Research Design:
This study is a prospective, open-label, single-cohort, phase I study to determine the feasibility of scanning with oral FDG. Participation will involve one scan with regular FDG and one scan with oral FDG within 14 days of each other. The study will be divided into 3 steps to test different uptake times and patient activity levels for protocol optimization. Participants cannot participate in more than 1 step.
This small pilot study aims to determine the optimal examination protocol and feasibility of ambulatory and oral application of [18F]FDG in conjunction with a latest-generation high-sensitivity LAFOV scanner system. Comparisons between the oral and SOC intravenous scans will be made using descriptive statistics.
Sample size estimate:
The sample size for study will be a pragmatic determination based on feasibility considerations. So as not to unduly burden the study with the long 1h dosimetry requirements from kinetic scanning, the investigators shall perform dosimetry in 5 subjects.
The sample size is designed to afford a preliminary check of the protocol's feasibility before moving to the next stage. Once the final protocol is reached (Step 3) - a minimum of N=10 patients will be available with a comparable protocol for an initial estimate of the technique's performance.
The data generated will afford a power calculation for a phase II trial if appropriate STEP 1: N=5 STEP 2: N=3 STEP 2(a): N=3 (optional) STEP 3: N=7
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Oral FDG scan and standard of care FDG scan | Experimental | Diagnostic Test: Oral FDG scanParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral FDG scanEvaluating the feasibility, scan quality and ease of administration when FDG is consumed orally rather than administered by IV. | Diagnostic test | Oral FDG scan and standard of care FDG scan |
Primary outcome
Number of hours for radiopharmaceutical to be cleared from stomach for optimal imaging
Time frame: Periprocedural
To identify an acceptable imaging time to achieve gastric clearance of the radiopharmaceutical (time post administration in hours)
Image quality compared to the standard of care FDG scan
Time frame: within 2 weeks of the 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).
To assess participant preference for this method of administering radiopharmaceutical
Time frame: periprocedural
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Cancers
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 1
Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
Solid Tumors
Recruiting
Improving Engagement in HIV and Cancer Care in Zimbabwe
Cancer, HIV
Not yet recruitingPhase 3
Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
Esophageal Cancer
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral FDG scan in people with Multiple Cancers and Multiple Indications Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hours for radiopharmaceutical to be cleared from stomach for optimal imaging (time frame: Periprocedural). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.