Blood and Lymph Conditions

Immune System Diseases

All Conditions

Sarcoidosis

Lymphoproliferative Disorders

Lymphatic Diseases

Hypersensitivity

Hypersensitivity, Delayed

In 10 healthy volunteers the radiation dosimetry, normal organ distribution, and safety of \[64Cu\]-Macrin injection will be studied.

In 30 subjects with a history of recent myocardial infarct, the radiation dosimetry, normal organ distribution, and safety of \[64Cu\]-Macrin injection will be studied. In addition, the ability of \[64Cu\] Macrin to concentrate at the infarct site will be correlated with cardiac MRI.

In 30 subjects with an epithelial malignancy the radiation dosimetry, normal organ distribution, and safety of \[64Cu\]-Macrin injection will be studied. In addition, the ability of \[64Cu\] Macrin to concentrate at the tumor site will be correlated with imaging and histopathology, where available.

In 30 subjects with sarcoidosis the radiation dosimetry, normal organ distribution, and safety of \[64Cu\]-Macrin injection will be studied. In addition, the ability of \[64Cu\] Macrin to concentrate at the tumor site will be correlated with imaging and histopathology, where available.

Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.

[64]Cu Macrin

Ralph Weissleder, MD, PhD

Aileen O'Shea, MD

Andrew Lewis, MD

To evaluate the safety of \[64Cu\] Macrin and its whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. To detect \[64Cu\]-Macrin accumulation in sites of disease in subjects with cancer, sarcoidosis or myocardial infarct.

Macrophages are phagocytic cells of the innate immune system. Their accumulation is a hallmark of many inflammatory diseases and they have diverse roles in tissue responses to infection and injury and in tissue repair. As macrophages have a tissue specific and often disease stage specific roles, future therapies directed at macrophage subtypes at certain points in the course of a disease may be more efficacious and result in less systemic side effects, as compared to conventional chemotherapeutics. \[64Cu\] Macrin is designed to detect macrophages by PET imaging. As a result, PET imaging can be used to identify inflammatory "hotspots" and quantitate local macrophage density non-invasively. The investigators studies in mice showed that \[64Cu\] Macrin has excellent pharmacological and pharmacokinetic profile with high target uptake and low retention in background tissues and organs.

The investigators wish to first evaluate in healthy human subjects the pharmacological and pharmacokinetic profile, and the overall safety of the new radiopharmaceutical \[64Cu\] Macrin. The investigators will then establish the concentration of \[64Cu\] Macrin in patients following myocardial infarct, in sarcoidosis and in cancer patients. In a subset of patients where tissue sampling is feasible, we will correlate tracer uptake on imaging to macrophage density on histopathology or with additional standard of care imaging studies.

Eligible subjects, including healthy volunteers and patients with sarcoidosis, cardiovascular disease and cancer, will be enrolled to undergo imaging with the PET Probe \[64\]Cu Macrin

Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.

Preliminary Evaluation of [64Cu] Macrin in Healthy Individuals and Subjects With Cardiovascular Disease, Sarcoidosis and Malignancy.

We will use established methods to provide quantitative information on the amount of \[64Cu\] Macrin radioactivity that accumulates in peripheral organs and brain. Dose-corrected imaging data will be processed using time-activity curves based on ROIs manually-drawn on MR data and projected onto PET datasets.

Probe uptake will be measured in organs affected by solid epithelial malignancies and compared to uptake in the uninvolved parts of the organs and in these organs in healthy volunteers. We expect greater uptake in the part of the organs affected by malignancy.

Probe uptake will be measured at a myocardial infarct and compared to uptake in the remainder of the heart and in the hearts of healthy volunteers. We expect greater uptake at the site of a myocardial infarction.

Probe uptake will be measured in the heart and lungs of patients with sarcoidosis and compared to uptake in these organs in healthy volunteers. We expect greater uptake in the organs affected by sarcoidosis.

To determine the sensitivity and specificity of \[64 Cu\] Macrin accumulation for the detection at sites of inflammation by comparing tracer accumulation to histopathology and/or standard of care imaging studies

Ralph Weissleder, MD

Professor of Radiology

Symptoms and General Pathology

Infections

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Inflammation

Communicable Diseases

Lymphatic Metastasis

Neoplasm Metastasis

Lymphadenopathy

Neoplasms, Unknown Primary

Pancreatic Neoplasms

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

the first pass is made with 5ml suction technique

the first pass is made with modified wet suction technique

the first pass is made with 5ml suction technique, then modified wet suction technique / 5ml suction technique/ modified wet suction technique is operated successively.

the first pass is made with modified wet suction technique, then 5ml suction technique/ modified wet suction technique/ 5ml suction technique is operated successively.

Bin Cheng, Doctor

Yun Wang, Doctor

The purpose of this study is to compare the diagnosis accuracy of modified wet suction technique and 5ml dry suction technique on solid occupying lesions.

Patients will be divided into two groups, arm A and arm B according to two different methods adopted in their first needle, which refers to the modified wet suction technique or 5ml dry suction technique.Take the solid occupying lesion diagnosis accuracy as the research major indicator to compare the the modified wet suction technique or 5ml dry suction technique as optimal efficiency test. Take classⅠerror, a=0.05, class II error, β=0.2, power=0.8, suppose that the diagnostic accuracy of dry suction technique to the solid occupying lesions is 75%, the diagnostic accuracy of modified wet suction technique to the solid occupying lesions is 85%, the minimum sample size are 248 patients with 5ml dry suction technique and 248 patients with modified wet suction technique, the 2x2 cross-over design is adopted, namely, each arm has 124 patients respectively. Considering factors including defluxion, 20% cases will be added to two arms, therefore, each arm has 148 patients respectively, the total number of patients is 296.

The statistics experts generated randomized serial numbers（001-296）according to same-size allocation ratio between arm A and arm B with Statistical Analysis System 9.2(SAS 9.2), a statistical software in the randomized block method. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 8, totally 37 randomized block. 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 arm A or arm B .The research people and patients in all trial centers should not know the randomized grouping number and relevant arms. The arm 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 investigator will puncture the lesion for four needle passes for all of them:For Arm A,5ml dry suction technique is adopted in their first needle, then modified wet suction technique/5ml dry suction technique/modified wet suction technique is operated successively;For Arm B, modified wet suction technique is adopted in their first needle, then 5ml dry suction technique/ modified wet suction technique /5ml dry suction technique is operated successively.Well,the 5ml dry suction technique is conducted as follow:after the needle puncturing into the lesion under ultrasound scanning, remove the stylet and connect the needle to syringe with 5ml negative pressure aspiration, then the needle will be moved to-and-fro within the lesion 20 times. Suction will be released before the needle is withdrawn from the lesion.And the modified wet suction technique is conducted as follow:the needle whose stylet is pulled out will be flushed with 2ml saline solution before puncturing when the lesion has been found, then puncture into the lesions and replace syringe with 5ml negative pressure aspiration, then the needle will be moved to-and-fro within the lesion 20 times. Suction will be released before the needle is withdrawn from the lesion.If no core tissues obtained or the operator determine insufficient specimen according to Macroscopic rapid on-site(MOSE) after the operations above, then remedy procedures will be done, and the punctuation process should be continued with the appropriate punctuation methods until the satisfactory specimens are obtained.Experts in cytology and pathology evaluate the specimen quality and make a diagnosis under the condition that they do not know punctuation methods. The evaluation and diagnosis of each specimen are made by two experts independently. If the two experts hold different opinions, they will make a conclusion after full discussion. If there are two or more cytological smears with same punctuation method, the highest-rate smear should be taken as the standard smear.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.

Case Report Form(CRF) will be filled by the researchers, every involved patient must have the CRF 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:（1）General principle①All statistical tests were two-sided. P\<0.05 is regarded that the difference is statistical significance.② Description of quantitative index will calculate the mean and the criteria deviation, description of classification index will describe the number and percentage of each type.（2） Statistical Analysis Method：① For measurement data, compare these data with baseline value during the screening period, adopt the deviation t-test, the variance analysis of cross-over experiment or the rank-sum test of cross-over experiment to make a comparison between these data and baseline value.② For enumeration data, adopt the paired x2-test(including CMH-x2 test) or Fisher's exact test to compare these data of each group.（3）Defluxion Analysis：The total defluxion rate of each group and the defluxion rate caused by adverse events are compared by x2-test or Fisher's exact test.（4）Analysis of baseline value balance：The indexes of some baseline values such as demographic data, vital signs, history of diseases and basic treatment are compared by group t-test and x2 test to measure the balance of each group. Baseline evaluation is made to full analysis set( FAS) and per-protocol set(PPS).（5）Validity Analysis：The primary index of validity analysis is the diagnostic accuracy of the 5ml dry pressure and modified wet pressure to the solid space-occupying lesions. The secondary indexes of validity analysis include the punctuation specimen quality of 5ml dry pressure and modified wet pressure, the diagnostic rate of the first needle of 5ml dry pressure / modified wet pressure and the incidence of complications for modified wet pressure and 5ml dry pressure. The rates of each two arms and Youden indexes are compared by the approximate normal z-test or the central-effect-considered Cochran Mantel Haenszel-x2(CMH-x2 )text.(6)Safety Analysis:The incidences of adverse events/ adverse reactions (including complications from punctuation) of each arm are compared by x2-test or Fisher's exact test and describe the adverse events occurred in this experiment by the list and the normal/abnormal changes of laboratory text results before and after test and the relationship between abnormal changes of laboratory text results and this diagnostic research.(7) All statistical analyses are completed by the professional statistical analysis software, SAS version 9.2.

Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions

Comparing of Modified Wet Suction Technique and Dry Suction Technique for Endoscopic Ultrasound -Guided Fine Needle Aspiration (EUS-FNA) of Solid Occupying Lesions: a Prospective Multi-center,Randomized,and Controlled Trial

The investigators' primary outcome measure is to compare the overall diagnostic accuracy of modified wet suction technique and dry suction technique to the solid occupying lesions.

The investigators'secondary outcome measure is to compare the diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the benign and malignant solid occupying pancreatic lesions and non-pancreatic lesions respectively.

The investigators'secondary outcome measure is to compare the cellularity and blood cell contamination of the solid occupying lesions with modified wet suction technique and 5ml dry suction technique.

Bin Cheng

professor

Lymphoma

Lymphosarcoma

Patients undergoing endoscopic ultrasound for solid mass lesions with a 22 G needle at University of Minnesota Medical center and Aurora St.Luke's Medical Center, Milwaukee, WI

RAJEEV ATTAM, MD

ROLE OF SUCTION IN EUS-FNA: Current suction technique involves suctioning the aspirate into the needle that has an air column. The needle is not flushed with any liquid prior to passing into the desired solid lesion. Suction is applied when the needle is within the lesion leading to aspiration of tissue into the needle. This is the standard technique and some have done with and without the stylet. There are some data that favor non use of a stylet.

WET SCTION TECHNIQUE:

Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the column of air with saline. The needle is now passed into the desired lesion. Suction is applied at maximal strength and needle moved back and forth within the lesion to obtain as aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a stylet and or flushing air into the needle with a syringe.

HYPOTHESIS The effect of suction for the purpose of aspirating cells and / or tissue during fine needle biopsy may be significantly improved by filling the column of the needle with a less compressible fluid. The volume of vacuum being pulled may be negatively impacted by the expansion of air within the needle. Replacing the air with sterile saline may thus improve the suction transferred to the needle tip by ensuring that the full volume of the vacuum syringe is transferred to the distal tip of the needle. This effect would be most pronounced in larger gauge needles which would have a larger internal volume. An additional benefit of filling the needle with saline prior to aspiration is the speed of the pressure transfer. The theory is that the air in the needle may absorb some of the force of the sudden application of vacuum. A column of saline in the needle may increase the velocity of the pressure transfer providing more tissue and less blood.

Endoscopic ultrasound (EUS) has become the modality of choice for imaging the gastrointestinal wall and surrounding structures. EUS is not only used for diagnostic purposes but is also useful in tissue acquisition by fine needle aspiration (FNA) thus helping in diagnosis and treatment of various lesions. EUS-FNA is being routinely used to sample various cystic and solid lesion involving the pancreas, liver, gastric wall, adrenal glands, kidney as well as lymph nodes in areas adjacent to the gastrointestinal tract.

EUS-FNA is performed by passing a needle through a working channel located within the echoendoscope. The needle passes out of the endoscope in the same plane as the ultrasound sensor, allowing the operator to visualize the path of the needle. This allows directed needle puncture of the lesion and avoidance of other structures such as blood vessels. After the needle is passed into the lesion of interest, varying degrees of suction is applied to obtain an aspirate. The needle is withdrawn from the scope channel and aspirate is pushed out of the needle either with a stylet or by using a syringe to pump air to flush out the aspirate for further cyto-pathological evaluation. The cells obtained at needle aspiration can help in differentiating benign from malignant, and also tell the origin of the tumor if malignant.

One of the advantages of EUS-FNA is that the sample can be quickly stained and processed in the procedure room and a diagnosis can be given to the endosonographer during the procedure. The cyto pathologist if unable to provide an accurate diagnosis on the site is at least able to assess the adequacy of cellularity. This optimal and in some centers 5-6 needle passes are routinely made and the cells sent to the cytopathological laboratory for further examination, preparation of cell block etc.,. The ability to make an accurate diagnosis, , is dependent on the quality of the sample obtained. Not all the centers have the capability of having an on site cytopathologist to assess the cellularity and or make a diagnosis at the bedside. Moreover if the cellularity is inadequate or if the diagnosis is uncertain, the patient has to undergo a repeat procedure resulting in increased costs, risks and also the agony of waiting for a diagnosis.

ROLE OF SUCTION IN EUS-FNA It was believed that applying suction to the needle while it is within the desired lesion, improves the quality of aspirate. However, recently there has been a trend to use less or no suction as that provides a "less bloody" specimen. The only randomized trial comparing suction to non suction techniques observed a higher sensitivity and negative predictive values for malignancy in the suction group compared with the non-suction group. In addition, bloodiness or contamination was not increased in the suction group.

Current suction technique involves suctioning the aspirate into the needle that has an air column. The needle is not flushed with any liquid prior to passing into the desired solid lesion. Suction is applied when the needle is within the lesion leading to aspiration of tissue into the needle. This is the standard technique and some have done with and without the stylet. There are some data that favor non use of a stylet.

WET SCTION TECHNIQUE:

Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the column of air with saline. The needle is now passed into the desired lesion. Suction is applied at maximal strength and needle moved back and forth within the lesion to obtain as aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a stylet and or flushing air into the needle with a syringe HYPOTHESIS The effect of suction for the purpose of aspirating cells and / or tissue during fine needle biopsy may be significantly improved by filling the column of the needle with a less compressible fluid. The volume of vacuum being pulled may be negatively impacted by the expansion of air within the needle. Replacing the air with sterile saline may thus improve the suction transferred to the needle tip by ensuring that the full volume of the vacuum syringe is transferred to the distal tip of the needle. This effect would be most pronounced in larger gauge needles which would have a larger internal volume. An additional benefit of filling the needle with saline prior to aspiration is the speed of the pressure transfer. The theory is that the air in the needle may absorb some of the force of the sudden application of vacuum. A column of saline in the needle may increase the velocity of the pressure transfer providing more tissue and less blood.

Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA

Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA of Solid Lesions. A Randomized, Prospective, Blinded, and Controlled Trial

The aspirate will be evaluated by a pathologist, blinded to the suction technique, to reach a cytological diagnosis. The pathologist will determine the quality of aspirate, grading it based on cellularity.

Cell block made from the aspirate will be evaluated for ability to reach a final pathological diagnosis.

The aspirate will be evaluated by a pathologist, blinded to the suction technique, for presence of contaminant cells and blood. The aspirate will be graded based on presence of blood and other contaminants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	NCT04843891	Sarcoid Cardiovascular ... Cancer	[64]Cu Macrin	18 Years - 80 Years	Massachusetts General Hospital
Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions	NCT02789371	Pancreas Neopla... Lymphatic Metas... Neoplasm Metast... Unknown Primary... Infection Inflammation Sarcoid Lymphadenopathy	the first pass ... the first pass ...	18 Years - 80 Years	Huazhong University of Science and Technology
Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA	NCT01720745	Cancer Infection Inflammation Tumor Sarcoid Lymphadenopathy Lymphoma		18 Years -	University of Minnesota

Spots Global Cancer Trial Database for sarcoid

Every month we try and update this database with for sarcoid 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 sarcoid

Every month we try and update this database with for sarcoid 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 sarcoid 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.