CancerPhase 4NCT02173964
Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)
A Phase 4 study testing pinaverium bromide and water in people with Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. Background 1. PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients. 2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT. 3. There is no widely-accepted method to reduce the bowel FDG uptake. 2. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- pinaverium bromide and water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any cancer patients
- Candidate of positron emission tomography/computed tomography
Who cannot join
- Diabetes mellitus
- Inflammatory bowel disease
- Irritable bowel syndrome
- Peritoneal carcinomatosis
- Peritonitis
- Abdominal pain
Show all 14Show fewer
- Diarrhea
- Medical test requiring bowel preparation within 1 month
- History of abdominal surgery
- Symptom or sign of colitis
- Pregnancy or lactation
- Hypersensitivity to pinaverium bromide
- Lactate intolerance
- Anit-depressant medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Clinical Trial of Pinverin (Pinaverium Bromide) to Reduce Bowel Uptake of FDG in a Variety of Cancer Patients Who Undergo FDG PET/CT
- Background
- PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients.
- Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.
- There is no widely-accepted method to reduce the bowel FDG uptake.
- Purpose
- To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG.
- Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.
- Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition.
- Method
- Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (~100mL).
- Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection.
- Primary outcome
- SUV (standardized uptake value) difference between pinverin administered patient group versus control group.
- SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pinaverium bromideDrug
Also called pinverin
pinverin 50 mg per oral single dose versus simple water ingestion
waterDrug
Also called water~100mL
same amount of water for pinverin administration
| Study group | Role | What they receive |
|---|---|---|
| pinaverium bromide | Experimental | pinaverium bromide 50 mg tablet per oral administration one time Receives: Drug: pinaverium bromide |
| water | Placebo comparator | water ~100mL Receives: Drug: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV (standardized uptake value)
SUV is the quantitative parameter of FDG uptake during PET/CT and represents the degree of relative FDG uptake in a specific lesion.
SUV is calculated as: (decay-corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi). The unit of SUV is g/mL.
Measured: 1 hour after FDG (the radiopharmaceutical for PET/CT) injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Woo Lee, Seoul National University Hospital
- Investigators
- Won Woo Lee, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173964
- Sponsor's protocol ID
- Pin-2014-SNUBH
- Status last verified
- Apr 2016
- First submitted
- 23 Jun 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Pinverin (Pinaverium Bromide) to Reduce Bowel Uptake of FDG in a Variety of Cancer Patients Who Undergo FDG PET/CT
- ClinicalTrials.gov ID
- NCT02173964
- Acronym / sponsor ID
- Pin-2014-SNUBH
- Conditions
- Cancer
- Keywords
- fluorodeoxyglucose, positron emission tomography, computed tomography, bowel, pinaverium bromide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Jun 2014 (estimated)
- 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.
- Background
- PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients.
- Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.
- There is no widely-accepted method to reduce the bowel FDG uptake.
- Purpose
- To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG.
- Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.
- Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition.
- Method
- Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (~100mL).
- Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection.
- Primary outcome
- SUV (standardized uptake value) difference between pinverin administered patient group versus control group.
- SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pinaverium bromide | Experimental | Drug: pinaverium bromidepinaverium bromide 50 mg tablet per oral administration one time |
| water | Placebo comparator | Drug: waterwater ~100mL |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any cancer patients
- Candidate of positron emission tomography/computed tomography
Key exclusion criteria (14 listed)
- Diabetes mellitus
- Inflammatory bowel disease
- Irritable bowel syndrome
- Peritoneal carcinomatosis
- Peritonitis
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 |
|---|---|---|
| pinaverium bromideAlso: pinverinpinverin 50 mg per oral single dose versus simple water ingestion | Drug | pinaverium bromide |
| waterAlso: water~100mLsame amount of water for pinverin administration | Drug | water |
Primary outcome
SUV (standardized uptake value)
Time frame: 1 hour after FDG (the radiopharmaceutical for PET/CT) injection
SUV is the quantitative parameter of FDG uptake during PET/CT and represents the degree of relative FDG uptake in a specific lesion. SUV is calculated as: (decay-corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi). The unit of SUV is g/mL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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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.
Won Woo Lee, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pinaverium bromide and water in people with Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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 14 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: finished, as of the sponsor's last update on 15 Apr 2016. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SUV (standardized uptake value) (time frame: 1 hour after FDG (the radiopharmaceutical for PET/CT) injection). 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 15 Apr 2016.