Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Subjects will undergo magnetic resonance imaging (MRI) with contrast. Magnetic resonance (MR)_freebreathing scan will be acquired. MR_inspiration scan will be acquired. MR_expiration scan will be acquired.

Magnetic Resonance Imaging (MRI)

Wensha Yang, Ph.D.

The overall aim of this study is to investigate a novel "dual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning.

Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and expiration (EXP) positions and characterize the changes in geometric relationships between the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification of patients who may benefit from the dual instance planning method.

Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. We hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.

Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study

Cedars-Sinai Medical Center

Assistant Professor

Carcinoma

Adenocarcinoma

Carcinoma, Neuroendocrine

Exocrine Pancreatic Insufficiency

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Neuroepithelioma

A prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy.

A sub-set (up to n=50) of the Demographic cohort patients will be tested to elucidate the most efficient diagnostic panel for PEI in pancreatic malignancy.

An extra assessment for PEI diagnosis consisting of a breath test (Pancreo-KIT breath test) will be carried out during the following 1-2 weeks after the first appointment (which takes around six hours to complete and involves the administration of bread spread with 13C butter followed by collection of the patient's breath in small plastic vials at timed intervals. The vials will subsequently be analyzed for 13C quantity; details in Appendix 6). Following these diagnostic tests, patients will complete an "acceptability questionnaire" to assess their opinion regarding the burden that these diagnostic tests may add.

Validation of the diagnostic panel designed and tested in Step-1 of this study and evaluation of dietician intervention (including Pancreatic Enzyme Replacement Therapy; PERT) and its impact in weight loss, symptom evolution, chemotherapy receiving rate, quality of life and overall survival.

Pancreo-Kit (Isomed Pharma, Madrid, Spain) is a breath test devised to measure Pancreatic Enzyme Insufficiency. It is a non-invasive method to obtain information about the digestion of consumed lipids; this in turn is informative about the exocrine enzyme activity of the pancreas (specifically pancreatic lipase). This kit is manufactured to EC directive 98/79/EEC and carries the CE mark.

The test is based on measurement of 13C which is a stable naturally occurring environmental isotope of carbon with a nucleus containing 6 protons and 7 neutrons (note, it is not radioactive).

Pancreo-KIT breath test

Juan W Valle, Professor

This is a prospective observational study which aims to evaluate;

The prevalence of pancreatic insufficiency in patients with pancreatic malignancies (adenocarcinoma and neuroendocrine tumours).

The most appropriate diagnostic strategy. The impact that an adequate diagnosis and treatment may have on patients' outcome.

Patients will prospectively receive a full nutritional assessment, pancreatic enzyme insufficiency (PEI) diagnosis and dietician education. This assessment will be performed as an outpatient in parallel with the medical oncology team, by the research dietician. This study will be performed in two steps (summarized in Figure 2);

Step-1 \| A prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy (this will be termed 'the demographic cohort'). A sub-set of these patients (n=50) will be tested to elucidate the most efficient diagnostic panel for PEI in pancreatic malignancy (this will be termed 'the diagnosis cohort').

Step-2 \| A prospective longitudinal validation of the diagnostic panel designed and tested in Step-1 and evaluation of dietician intervention (including PERT) and its impact in weight loss, symptom evolution, chemotherapy receiving rate, Quality of Life and overall survival (this will be termed 'the follow-up cohort' and will include up to n=50 patients).

All patients included in both steps will have a full nutritional assessment at baseline, and PERT treatment (as per standard of care if considered appropriate). Patients in the follow-up cohort will be reviewed (at least every 3 months for a maximum of 6 months since study entry) by dietician for further intervention and assessment.

Pancreatic Cancer Dietary Assessment Study

Prospective Observational Study of Prevalence, Assessment and Treatment of Pancreatic Insufficiency in Patients With Pancreatic Malignancies

Prevalence will be given as a percentage of all patients with pancreatic neoplasms with evidence of pancreatic enzyme insufficiency

Percentage of patients with documented biochemical evidence of pancreatic enzyme insufficiency with related symptoms

Described as a percentage of successful tests completed by patients

To quantify acceptability on a pre-defined score for each of the tests.

Themes will be described in a semi-quantitative report arising from the interviews.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study	NCT02024997	Pancreatic Canc...	Magnetic Resona...	18 Years -	Cedars-Sinai Medical Center
Pancreatic Cancer Dietary Assessment Study	NCT03616431	Pancreatic Neop... Pancreas Adenoc... Well-Differenti... Malignant Neopl...	Pancreo-KIT bre...	18 Years -	The Christie NHS Foundation Trust
Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study	NCT02024997	Pancreatic Canc...	Magnetic Resona...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for pancreatic malignancy