Pancreatic Cysts
Conditions
Keywords
Premalignant, Malignant
Brief summary
This research study is a pilot study. In this pilot study we are testing the safety of a procedure. Investigational means that the Albumin bound paclitaxel (Abraxane) is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved Abraxane injection for your type of medical condition. Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. As part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.
Detailed description
You will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Screening tests include the following: medical history, performance status, assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria you will not be able to participate in this research study. As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity. The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the EUS-FNA. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up CT to see what happened to the cyst. You will continue to have routine follow up for your medical problems.
Interventions
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mucinous cysts (premalignant or malignant cysts of the pancreas) * Normal organ and marrow function * Baseline CT within 6 months of enrollment
Exclusion criteria
* Pregnant or breastfeeding * Acute active pancreatitis * Complicated pancreatic cysts * Subjects who do not speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Pancreatitis | 3-10 months (median 6 months) after injection therapy | Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts | immediately after procedure | The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study. |
| Size of Cystic Lesion | 3-10 months (median 6 months) after injection therapy | Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Albumin Bound Paclitaxel Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Albumin Bound Paclitaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Cyst diameter | 28.4 mm |
| Location of cyst Body | 1 Participants |
| Location of cyst Head | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Frequency of Pancreatitis
Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.
Time frame: 3-10 months (median 6 months) after injection therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Albumin Bound Paclitaxel | Frequency of Pancreatitis | 0 Participants |
Secondary
Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts
The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.
Time frame: immediately after procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albumin Bound Paclitaxel | Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts | 4 units on a scale |
Secondary
Size of Cystic Lesion
Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.
Time frame: 3-10 months (median 6 months) after injection therapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Albumin Bound Paclitaxel | Size of Cystic Lesion | Reduction | 3 Participants |
| Albumin Bound Paclitaxel | Size of Cystic Lesion | Persistent | 1 Participants |
| Albumin Bound Paclitaxel | Size of Cystic Lesion | Increase | 1 Participants |