Solid TumorNCT03109639
A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions
A study testing Conventional EUS FNA needle and Acquire FNB device in people with Solid Tumor and Histological Type of Neoplasm, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the technique of choice to evaluate solid gastrointestinal (GI) lesions. The tissue acquired using this technique is essential for diagnosis of diseases like sub-mucosal masses (GIST), lymphoma, autoimmune pancreatitis and pancreatic cancer. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Solid Tumor, Histological Type of Neoplasm
- What is being tested?
- Conventional EUS FNA needle and Acquire FNB device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Apr 2017to 30 Nov 2017
- Phase
- Interventional
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 21 years
- All patients with solid lesions (pancreas, lymph nodes, metastasis, liver and sub-epithelial lesions) referred for EUS- FNA
- Solid lesions confirmed by at least a single investigational modality, mainly CT, MRI or endoscopy
- Able to comply with the study procedure and provide informed consent.
Who cannot join
- Presence of active bleeding
- Presence of coagulopathy as evidenced by INR>1.5 and platelets <50,000
- Inability to sample because of intervening blood vessels seen during imaging or EUS.
- Poor patient tolerance to procedure
- Concurrent intake of anti-coagulants and thienopyridine (e.g clopidogrel) in patients who require anti-platelet therapy.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the technique of choice to evaluate solid gastrointestinal (GI) lesions. The tissue acquired using this technique is essential for diagnosis of diseases like sub-mucosal masses (GIST), lymphoma, autoimmune pancreatitis and pancreatic cancer. Also the availability of adequate tissue will enable performance of molecular profiling and personalized oncologic therapy. The current needle used for tissue acquisition rarely provides tissue blocks needed for histology assessment. Hence, a better needle device with a good safety profile is needed to solve this technical difficulty. The new AcquireTM fine needle biopsy device could over come this difficulty because of its unique designs. The additional cutting edge surface allows better tissue access and provides core tissue (>90%) for histology. The safety profile of this new device is comparable to the conventional FNA needle thereby making it an ideal device for tissue acquisition.
Read the detailed description
Endoscopic ultrasound has become the preferred method to characterise gastrointestinal (GI) wall and peri-gastrointestinal masses. A major strength is that it can be used to guide fine needle aspiration (EUS-FNA) of any lesion in the wall or within 5cm from the GI tract. However, EUS-FNA has a major drawback- it rarely able to provide tissue blocks. Thus multiple passes, each of them time consuming, are necessary to obtain adequate cellular samples for cytological analysis. A radically new design of FNA needle (AcquireTM) has recently become available. The needle has an additional cutting edge surface, which allows better tissue access and acquires intact large core samples. The flexibility of the needle permits its use in tortuous anatomy, thereby making it an ideal needle for FNA. The new AcquireTM fine needle biopsy device (FNB) provides core tissue (>90%) for histology. This ability of the needle will enable us to obtain core tissue in fewer passes and make a precise diagnosis. However, at present there is no prospective randomized study to validate this finding.
The investigators hypothesize that the unique cutting system of Acquire TM fine needle biopsy (FNB) device will improve the specimen adequacy of solid intestinal and extra-intestinal lesions by providing a good core tissue for analysis.
- Conditions
- Solid Tumor, Histological Type of Neoplasm
- Being tested
- Conventional EUS FNA needle, Acquire FNB device
- Keywords
- EUS, FNA, FNB, Core Histology
- Medical subject headings
- Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional EUS FNA needleDevice
Participants randomised to Group A will undergo tissues acquisition using the Conventional EUS FNA needle and then crossed over to receive the experimental Acquire EUS- FNB device.
Acquire FNB deviceDevice
Participants randomised to Group B will undergo tissue acquisition using the experimental Acquire EUS FNB device and then crossed over to receive the conventional EUS FNA needle
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | This group will undergo tissue acquisition using the conventional EUS-FNA needle followed by the experimental Acquire EUS- FNB needle Receives: Device: Conventional EUS FNA needle; Device: Acquire FNB device |
| Group B | Active comparator | This group will undergo tissue acquisition using the experimental Acquire EUS- FNB needle followed by the conventional EUS-FNA needle Receives: Device: Conventional EUS FNA needle; Device: Acquire FNB device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue adequacy rate will be measured by assessing for the presence of histological core tissue representative of the lesion in the samples obtained using the two needles
The samples will be analyzed by the blinded pathologist for presence of histological core. Based on the presence of histological core, the sample will be graded optimal or suboptimal. Optimal specimens are those in which the procured material enabled satisfactory assessment of histologic architecture. Suboptimal specimens are those in which the quality of the core is inadequate or unsatisfactory for the assessment of histologic architecture
Measured: 8 months
Secondary outcomes (2)
Quantification of the sample obtained using the two EUS needles will be assessed by measuring the DNA and RNA concentration
Both cell block and core biopsies will be deparafinized and extraction with Qiagen RNA/ DNA kit will be performed. Both DNA and RNA will be quantified by Qubit system
Measured: 8 months
Qualification of the sample obtained using the two needles will be performed by spectroscopic analysis.The ratio of absorbance at 260 nm and 280nm; the ratio of absorbance at 260nm and 230nm will be measured
Spectroscopic analysis will be performed to assess the purity samples. The 260/280 and 260/230 ratios will be measured. A lower ratio may indicate the presence of impurities.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start13 Apr 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The participants will be randomised to one of the two groups. The first group will undergo tissue acquisition using the conventional EUS needle. After this, the lesion will be punctured again using the experimental Acquire EUS FNB needle to obtain tissue. In the second group, the experimental Acquire EUS FNB needle will be used first followed by the conventional needle to acquire tissue.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109639
- Sponsor's protocol ID
- EUS01042017
- Status last verified
- Mar 2020
- First submitted
- 1 Apr 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions
- ClinicalTrials.gov ID
- NCT03109639
- Acronym / sponsor ID
- EUS01042017
- Conditions
- Solid Tumor, Histological Type of Neoplasm
- Keywords
- EUS, FNA, FNB, Core Histology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 12 Apr 2017 (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.
Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the technique of choice to evaluate solid gastrointestinal (GI) lesions. The tissue acquired using this technique is essential for diagnosis of diseases like sub-mucosal masses (GIST), lymphoma, autoimmune pancreatitis and pancreatic cancer. Also the availability of adequate tissue will enable performance of molecular profiling and personalized oncologic therapy. The current needle used for tissue acquisition rarely provides tissue blocks needed for histology assessment. Hence, a better needle device with a good safety profile is needed to solve this technical difficulty. The new AcquireTM fine needle biopsy device could over come this difficulty because of its unique designs. The additional cutting edge surface allows better tissue access and provides core tissue (>90%) for histology. The safety profile of this new device is comparable to the conventional FNA needle thereby making it an ideal device for tissue acquisition.
Detailed description
Endoscopic ultrasound has become the preferred method to characterise gastrointestinal (GI) wall and peri-gastrointestinal masses. A major strength is that it can be used to guide fine needle aspiration (EUS-FNA) of any lesion in the wall or within 5cm from the GI tract. However, EUS-FNA has a major drawback- it rarely able to provide tissue blocks. Thus multiple passes, each of them time consuming, are necessary to obtain adequate cellular samples for cytological analysis. A radically new design of FNA needle (AcquireTM) has recently become available. The needle has an additional cutting edge surface, which allows better tissue access and acquires intact large core samples. The flexibility of the needle permits its use in tortuous anatomy, thereby making it an ideal needle for FNA. The new AcquireTM fine needle biopsy device (FNB) provides core tissue (>90%) for histology. This ability of the needle will enable us to obtain core tissue in fewer passes and make a precise diagnosis. However, at present there is no prospective randomized study to validate this finding.
The investigators hypothesize that the unique cutting system of Acquire TM fine needle biopsy (FNB) device will improve the specimen adequacy of solid intestinal and extra-intestinal lesions by providing a good core tissue for analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomised to one of the two groups. The first group will undergo tissue acquisition using the conventional EUS needle. After this, the lesion will be punctured again using the experimental Acquire EUS FNB needle to obtain tissue. In the second group, the experimental Acquire EUS FNB needle will be used first followed by the conventional needle to acquire tissue.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Conventional EUS FNA needle, Device: Acquire FNB deviceThis group will undergo tissue acquisition using the conventional EUS-FNA needle followed by the experimental Acquire EUS- FNB needle |
| Group B | Active comparator | Device: Conventional EUS FNA needle, Device: Acquire FNB deviceThis group will undergo tissue acquisition using the experimental Acquire EUS- FNB needle followed by the conventional EUS-FNA needle |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than 21 years
- All patients with solid lesions (pancreas, lymph nodes, metastasis, liver and sub-epithelial lesions) referred for EUS- FNA
- Solid lesions confirmed by at least a single investigational modality, mainly CT, MRI or endoscopy
- Able to comply with the study procedure and provide informed consent.
Key exclusion criteria (6 listed)
- Presence of active bleeding
- Presence of coagulopathy as evidenced by INR>1.5 and platelets <50,000
- Inability to sample because of intervening blood vessels seen during imaging or EUS.
- Poor patient tolerance to procedure
- Concurrent intake of anti-coagulants and thienopyridine (e.g clopidogrel) in patients who require anti-platelet therapy.
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 |
|---|---|---|
| Conventional EUS FNA needleParticipants randomised to Group A will undergo tissues acquisition using the Conventional EUS FNA needle and then crossed over to receive the experimental Acquire EUS- FNB device. | Device | Group A, Group B |
| Acquire FNB deviceParticipants randomised to Group B will undergo tissue acquisition using the experimental Acquire EUS FNB device and then crossed over to receive the conventional EUS FNA needle | Device | Group A, Group B |
Primary outcome
Tissue adequacy rate will be measured by assessing for the presence of histological core tissue representative of the lesion in the samples obtained using the two needles
Time frame: 8 months
The samples will be analyzed by the blinded pathologist for presence of histological core. Based on the presence of histological core, the sample will be graded optimal or suboptimal. Optimal specimens are those in which the procured material enabled satisfactory assessment of histologic architecture. Suboptimal specimens are those in which the quality of the core is inadequate or unsatisfactory for the assessment of histologic architecture
2 secondary outcomes
Quantification of the sample obtained using the two EUS needles will be assessed by measuring the DNA and RNA concentration
Time frame: 8 months
Qualification of the sample obtained using the two needles will be performed by spectroscopic analysis.The ratio of absorbance at 260 nm and 280nm; the ratio of absorbance at 260nm and 230nm will be measured
Time frame: 8 months
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 19 Mar 2020.
- Individual participant dataSharing planned: No
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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.
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 Conventional EUS FNA needle and Acquire FNB device in people with Solid Tumor and Histological Type of Neoplasm, run by Singapore General Hospital at 1 site in Singapore.
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 4 inclusion and 6 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 19 Mar 2020. 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 Singapore. 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?
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?
Tissue adequacy rate will be measured by assessing for the presence of histological core tissue representative of the lesion in the samples obtained using the two needles (time frame: 8 months). 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 19 Mar 2020.