Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vitamins

Anesthetics

Acetic Acid

Retinol acetate

Under local anaesthesia, taking proper aseptic precautions, 40% acetic acid (total dose not exceeding 3 times the diameter of the mass, (not more than 2ml in one sitting), will be injected into the mass through the percutaneous route

Under aseptic conditions and local anesthesia, the needle electrode would be introduced percutaneously into the tumor under ultrasound guidance.

Subrat K Acharya, DM

The purpose of this study is to assess the efficacy of Radiofrequency ablation (RFA) and percutaneous acetic acid ablation (PAI) in the management of small hepatocellular carcinoma (HCC) in patients of cirrhosis of liver.

Setting The study would be conducted at the All India Institute of Medical Sciences, New Delhi, a tertiary care teaching hospital, in the departments of Gastroenetrology and Radiodiagnosis.

Sample size Taking RFA as a standard procedure with an estimated success rate of 95%, a sample size of minimum 27 for each arm is required to detect an equivalence difference of 10%, assuming that PAI has a success rate of 85%. This sample size is expected to provide a power of 80%.

Randomization

* Stratified randomization of Child A and B will be done.
* Randomization into A (Acetic acid) and B (Radiofrequency ablation) will be done.

Diagnostic criteria

* Cirrhosis of liver- Diagnosis will be founded on the basis of clinical, biochemical, imaging and endoscopy findings.

Hepatocellular carcinoma- when any one of the following is present

1. Two imaging modalities (dual phase CT (DPCT)/ contrast enhanced Magnetic Resonance Imaging (MRI)) showing arterialization of the hepatic mass
2. AFP more than 400ng/ml along with arterialisation on one imaging modality (DPCT/ contrast enhanced MRI)
3. Fine needle aspiration cytology (FNAC)

Definitions

1. Local recurrence : When the Triple phase CT shows-

   * An area of nodular enhancement that abuts or surrounds the ablation defect or protrudes into the low attenuating necrotic tissue (may sometimes be seen only on arterial phase of CT)
   * Recurrent soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma.
2. Fresh lesion- When a new lesion is seen in the liver at a site other than the primary site of the treated lesion with normal liver parenchyma intervening in between will be considered as a fresh lesion.
3. Residual disease or incomplete ablation When the follow up Triple phase CT shows-

   * Residual nodular enhancement that abuts or surrounds the low attenuating ablation defect or protrudes into the low attenuating necrotic tissue (may sometimes be seen only on arterial phase of CT)
   * Residual soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma.
   * Concenteric hyperemia around the low attenuating defect showing area of focal nodularity or asymmetric thickness.
4. End point of ablation When the Triple phase CT shows-

   * A homogenous, well defined, uniformly low attenuating defect larger than the pretreatment size.
   * No residual soft tissue seen within or at the periphery of the low attenuating defect
   * Concentric hyperemia around the low attenuating defect of uniform thickness with no focal nodularity.

Follow up

1. Clinical follow up

   * All patients would be followed up in the Liver clinic monthly unless their clinical condition warrants earlier follow up
   * Liver function tests/ complete blood count would also be done at each visit and Alfafetoprotein (AFP) every six months
   * Patient tolerance, child's status would be estimated.
2. Imaging follow up

   * At one month, a dual phase CT would be done to ascertain the local response to therapy and the need to repeat the procedure. After achieving the end point after ablation (PAI and RFA, the DPCT would be done at 3 and 6 monthly intervals.

Duration of follow up - Since more than 80% recurrence occurs in 2 years therefore the duration of follow up would be 2 years after ablation.

Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis

Number of patients developing any complications during and after procedure will be noted.

Child status is calculated from the following 5 parameters

1. Bilirubin \< 2: 1, 2-3: 2 and \> 3 : 3 points
2. Albumin: \> 3.5: 1, 2.8-3.5 : 2 and \<2.8: 3 points
3. Prothrombin time( seconds over control): 1-3: 1, 4-6: 2 and \> 6: 3
4. Encephalopathy: None: 1, (grade 1 and 2): 2 and (grade 3 and 4): 3
5. Ascites: Absent: 1, slight: 2 and moderate: 3

Child A: score 5-6, Child B: 7-9 and Child C: 10 or more

All India Institute of Medical Sciences, New Delhi

Proffessor and Head

Behaviors and Mental Disorders

Quality of Life

Hematinics

Liver Extracts

AMT2003

Hubert Blum, Prof. Dr. med. Dr. h. c.

The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma

The primary endpoint is best overall response rate within 20 weeks after registration

The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.

The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.

Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003

A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003

Auron Healthcare GmbH

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Trastuzumab

Mitogens

Pertuzumab

Radiopharmaceuticals

Antineoplastic Agents, Immunological

Radiopharmaceutical 111In-labeled Pertuzumab given intravenously prior to SPECT-CT imaging.

111In-PmAb will be provided ready for injection in a vial by Dr. Reilly's laboratory.

111In-Pertuzumab + SPECT-CT

Mark Levine

Raymond Reilly

Kathleen Pritchard

The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to treatment with Trastuzumab.

Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)

Imaging With 111In-Pertuzumab to Predict Response to Trastuzumab in HER2 Positive Metastatic or Locally Advanced Breast Cancer

The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 8 (Day 8 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.

The safety, i.e. toxicities, attributable to 111In-Pertuzumab injections will be evaluated using the National Cancer Institute (NCI) Common Termination for Adverse Events Version 4.

The pharmacokinetics of 111In-PmAb and tumour and normal tissue localization properties of 111In-PmAb will be measured. Standard PK parameters (t1/2 alpha, t1/2β, V1, Vss and CL) will be calculated.

The dose of 111In-PmAb that is associated with the optimal SPECT-CT images will be established.

The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 36 (Day 36 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.

Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis	NCT01438437	Hepatocellular ...	PAI RFA	12 Years - 70 Years	All India Institute of Medical Sciences, New Delhi
Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003	NCT00405873	Hepatocellular ...	AMT2003	18 Years - 79 Years	Auron Healthcare GmbH
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)	NCT01805908	Breast Cancer	111In-Pertuzuma...	18 Years -	Ontario Clinical Oncology Group (OCOG)

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