Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Core biopsy

The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.

Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules

Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules, A Prospective Study

Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology

Alexandria University

Kafrelsheikh University

Dr, Assistant lecturer of general surgery

Digestive System Diseases

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Stromal Tumors

Lymphadenopathy

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Lymphatic Diseases

Pancreatic Cancer

Fine needle aspiration

Fine needle biopsy

Srinadh Komanduri

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.

Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.

The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB

As above. Crossover to FNA or FNB occurs after 3 passes without adequate material

Northwestern University

Associate Professor of Medicine

Fine needle aspiration: Fine needle aspiration

Fine Needle Aspiration

Fine needle biopsy

Fine needle biopsy: FNB

Fine Needle Biopsy

fine needle aspiration

Fine needle aspiration: Fine needle aspiration

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Diagnostic Yield of EUS-FNB and EUS-FNA

Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB.

Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB

fine needle aspiration to fine needle biopsy

EUS-FNA to EUS-FNB

Fine Needle Aspiration to Fine Needle Biopsy

Fine needle biopsy to fine needle aspiration

EUS-FNB to EUS-FNA

Fine Needle Biopsy to Fine Needle Aspiration

Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen.

Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)

fine needle aspiration

Fine needle aspiration: Fine needle aspiration using endoscopic ultrasound-FNA needles. This was the standard of care arm

Fine Needle Aspiration (FNA)

Fine Needle biopsy

Fine Needle biopsy: FNB, test arm for core biopsies, endoscopic ultrasound-FNB

Fine Needle Biopsy (FNB)

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Lymphatic Metastasis

Neoplasms, Unknown Primary

Neoplastic Processes

Pancreatic Diseases

EUS-FNA (EchoTip Ultra)

EUS-FNB (EchoTip ProCore)

Bin Cheng, Doctor

Jinlin Wang, Doctor

The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.

The study subjects are divided into two groups: the EUS-FNA(22G EchoTip Ultra needles) Group and EUS-FNB group(22G EchoTip ProCore needles).Take the malignant occupying lesion diagnosis accuracy as the research major indicator to compare the EUS-FNB group and EUS-FNA group as optimal efficiency test. Take the class I error a=0.05, class II error β=0.15, power=0.85. Suppose the malignancy diagnosis accuracy is 80%, while that of FNB is 93%. The two trial groups be randomly allocated in 1:1, suppose the malignancy cases take 70% of the whole case, and considering the shedding factors , extra 20% cases should be included. So the estimated cases numbers is 204 cases for EUS-FNB group and 204 cases for EUS-FNA group, totally 408 cases in this trial.

Done by professional statistical people with randomized block grouping method and SAS 9.2 statistical software to generate randomized serial number（001-408）for the two groups in 1:1 manner. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 8, totally 51 randomized block. The randomized grouping will be generated in duplicate copies and sealed. One copy send to trial centers for patient allocating, and the another copy be saved by the trial applicant unit. Every trail centers will be responsible for the screening of qualified patients, rank them in visit time to get the randomized grouping number so as to determine them goes to the EUS-FNA or EUS-FNB.The research people and patients in all trial centers should not know the the randomized grouping number and relevant groups. The group name will be sealed under scratch card. Every trial patients will get a unique randomized number, and it will not change through out the whole trial.

Use the inclusion and exclusion criteria to observe the patients and do relative inspections, and confirm if the patients qualified or not to the trial. Record the result of last time test before the treatment. Although it is better to get the informed consent before doing all kinds of observation and tests, if for some reason, the medical imaging examination has completed, as long as the imaging examination was done within 3 weeks before the needle biopsy, it can still be collect as baseline data (imaging examination can be done at other hospitals, but the trial center should issue a new evaluation report 1 week before the patient join the trial group); other lab test items done at 2 weeks before the needle biopsy can still be collect as baseline data for pre-research use, but these tests should be done at the trail center hospital so as to guarantee the data trace ability.

The investigators will do the needle passes for 4 times for all of them:the 1-2 needle passes with Slow-Pull and the 3-4 needle passes with Vacuum suction.If no core tissues obtained or the operator/onsite pathologist determine insufficient specimen after the operations above, then remedy procedures will be done, the operator use proper puncture method to continue the remedy biopsy.After the first round of needle biopsy, if the trial patient cannot be diagnosed, by getting the agreement of the patient, the patient will be cross-over to another trial group and do needle biopsy again on the same lesion 1 week later with the method mentioned above.Without knowing the needle biopsy type, the cytologist and pathologist evaluate the specimen quality and make diagnosis. Every specimen will be independently evaluated and diagnosed by 2 experts. If the 2 experts have different judgments, then these two experts discuss together and make the final diagnose discussion. If the same sample has 2 or more cytology smear slides, than take the highest score slide as the result.Follow up (outpatient follow up or telephone follow up) the patients at 1 week, 12 weeks and 36 weeks after the needle biopsy and collect the patients clinical data and confirm their final diagnosis.

During the trial, if severe adverse event occurs, the trialed center must take immediate actions necessary to guarantee the trialed patients' safety. Once severe adverse event occurs, the researchers should inform the trial applicant and the trail center's ethics committee within 24 hours after the researchers gets to know the adverse event. And the researchers should also fax the report to State Food and Drug Administration of China and the local provincial food and drug administration. After receiving the report, the applicant should inform other clinical trial centers within 24 hours. All the severe adverse events should be filed at group leader medical center and other trial centers.

CRF(Case Report Form ) will be filled by the researchers, every involved patient must have the CRF(Case Report Form ) filled. This will be audited by clinical monitor and handed over to data administrator to input and manage data, the first copy will be kept by the applicant, the second copy will go to the trial center, and the third copy will be kept by the trail researchers.The data input and management will be taken care by specially assigned person. In order to guarantee the data accuracy, data input will be done twice by two independent data administrators, by computerized and manual verifying, hand over the data to statistical experts to do blind check and statistic analyzing.For the questions and doubts within the case report form, the data administrator make DRQ and via the clinical monitor asking the researchers. The researchers will answer and feed back as soon as possible. According to the researchers answer, data administrator will do the data modifying, confirming or inputting, and when necessary send out DRQ again.After blind audition and confirming that the established data base is correct, major researchers, applicant and the statistic analyzing people lock the data. The locked data will not be changed, and the data base will be handed over to statistical analyzer to do the statistic analyze according to the statistic analyzing plan. Problems found after data locking can be modified during the statistic analyzing procedure.This will be done by specialized statistic analyzing people according to the predetermined statistic analyzing plan. The statistic analyze will be carried out according to intention principle confirmed full analysis set and per-protocol set principle. After completing the statistic analyzing, the statistic analyzer issue the statistic analysis report and send this to major researchers to write the study report.

Statistic analyzing plan:⑴ General principle:① all the statistic tests are use the two-tailed-test method, P\<0.05 will be thought as the tested difference is statistical significance. ② the quantitative indicator description will calculate the Mean and Standard deviation. The classification indicator description will describe the cases and percentage of all types of cases. ⑵ Statistic analyzing method:① for the measurement data, compare it with the baseline value at selection period, use paired t-test or symbol rank sum test to compare with the before-after-difference within the group.② for the counting data, use x2 test to compare the groups. ⑶ Shedding analysis:Comparison of groups'total shedding rates and the shedding rates caused by adverse events will use x2 test or Fisher's exact test method. ⑷ The baseline value's equilibrium analysis: Use group t test or x2 test to compare the demography info and vital signs, disease history, and basic treatment and other indicators of baseline value, so as to measure the balance of the groups. The baseline evaluation will be done on FAS（full analysis set) and PPs(per-protocol set). ⑸ Effectiveness analysis:The major indicator of effectiveness analysis is the diagnostic accuracy on malignant disease, and the indicators of second effectiveness include the percentage of Grade A specimen and complications rate etc. while the two groups rate and the Youden index comparison will use approximate normal Z test or use central effect x2 test.(6) Safety analysis:Use x2 test or Fisher's exact test to compare the adverse event/adverse reaction (include biopsy complications) rates between the groups. And use table to describe the adverse events during this trial project; the lab test results before and after the trial, the normal/abnormal changing condition and the relationship with this trial research when abnormal changes happened.

Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion

Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB（Endoscopic Ultrasonography-Fine Needle Biopsy ） and EUS-FNA（Endoscopic Ultrasonography-Fine Needle Aspiration ） on Solid Occupying Lesion

The investigators' primary outcome measure is to compare the the diagnostic yield (%) on malignancy of EUS-FNA to EUS-FNB

The amount of blood contamination and cellularity at each sample according to EUS-FNA and EUS-FNB with slow-pull or suction will be measured.

Huazhong University of Science and Technology

professor

This group will undergo tissue acquisition using the conventional EUS-FNA needle followed by the experimental Acquire EUS- FNB needle

This group will undergo tissue acquisition using the experimental Acquire EUS- FNB needle followed by the conventional EUS-FNA needle

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.

Conventional EUS FNA needle

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

Acquire FNB device

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.

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.

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.

The pathologist will be blinded to the needle used for specimen collection.

A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions

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

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules	NCT04759053	Thyroid Nodule Thyroid Disease... Thyroid Gland; ...	FNB Core biopsy	18 Years - 65 Years	Kafrelsheikh University
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle	NCT01769248	Pancreatic Canc... Lymphadenopathy Gastrointestina...	Fine needle asp... Fine needle bio...	18 Years - 90 Years	Northwestern University
Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion	NCT02327065	Pancreas Neopla... Lymphatic Metas... Neoplasm Metast... Unknown Primary...	EUS-FNA (EchoTi... EUS-FNB (EchoTi...	18 Years -	Huazhong University of Science and Technology
A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions	NCT03109639	Solid Tumor Histological Ty...	Conventional EU... Acquire FNB dev...	21 Years - 99 Years	Singapore General Hospital
A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions	NCT03109639	Solid Tumor Histological Ty...	Conventional EU... Acquire FNB dev...	21 Years - 99 Years	Singapore General Hospital
A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions	NCT03109639	Solid Tumor Histological Ty...	Conventional EU... Acquire FNB dev...	21 Years - 99 Years	Singapore General Hospital

Spots Global Cancer Trial Database for fnb

Every month we try and update this database with for fnb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fnb

Every month we try and update this database with for fnb cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fnb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.