| CTRI Number |
CTRI/2010/091/001052 [Registered on: 12/07/2010] |
| Last Modified On: |
05/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cohort Study |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A phase 2, open-label test-retest study to assess the reproducibility of quantitative measurements of 18F uptake by solid tumours using PET imaging following intravenous administration of AH111585 (18F) Injection |
Scientific Title of Study
Modification(s)
|
A phase 2, open-label test-retest study to assess the reproducibility of quantitative measurements of 18F uptake by solid tumours using PET imaging following intravenous administration of AH111585 (18F) Injection |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| GE-135-004 |
Other |
| NCT00918281 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr R V Parameshwaran |
| Designation |
MBBS DRM DNB (Nuclear Medicine), MNAMS, Consultant and Head of Nuclear Med PET-CT Division |
| Affiliation |
|
| Address |
Manipal Hospital, Dept of Nuclear Med and PET-CT Division
#98, Rustom Bagh, Airport Road
Bangalore
KARNATAKA
560017
India |
| Phone |
08025024214 |
| Fax |
08025268912 |
| Email |
parameswaran@manipalhealth.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vishal Pandit |
| Designation |
Medical Advisor |
| Affiliation |
GE Healthcare Pvt. Ltd. |
| Address |
GE Healthcare Pvt. Ltd.
Vipul Tech Square, Sector 43
Golf Course Raod, Gurgaon
122009
Gurgaon
HARYANA
122002
India |
| Phone |
09999316602 |
| Fax |
911244906000 |
| Email |
vishal.pandit@ge.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Vishal Pandit |
| Designation |
|
| Affiliation |
|
| Address |
GE Healthcare Pvt Ltd
Vipul Tech Square, Sector 43
Golf Course Road, Gurgaon
Gurgaon
HARYANA
122009
India |
| Phone |
09999316602 |
| Fax |
01244906000 |
| Email |
vishal.pandit@ge.com |
|
Source of Monetary or Material Support
Modification(s)
|
| GE Healthcare Pvt. Ltd.
Vipul Tech Square, Sector 43
Golf Course Road, Gurgaon
122009, Haryana, India |
|
Primary Sponsor
Modification(s)
|
| Name |
GE Healthcare Pvt Ltd |
| Address |
Vipul TechSquare 1st Floor Golf Course Road Sector 43 Gurgaon 122009
Haryana India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Republic of Korea
Sweden
United Kingdom |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. K.G. Kallur, Director- PET-CT & Cyclotron |
Bangalore Institute of Oncology, |
HCG Towers, #8, P. Kalinga Rao Road,,Sampangi Ram Nagar-560027
Bangalore
KARNATAKA |
080 40206000
09844083662
kumarkallur@yahoo.com.sg |
| Dr R V Parameshwaran |
Manipal Hospital, |
#98 Rustom Bagh, ,Airport Road, -560017
Bangalore
KARNATAKA |
08025024214
08025268912
parameswaran@manipalhealth.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, HealthCare Global Enterprises Ltd., HCG Towers, #8 P.Kalinga Rao Road, Sampangi Ram Nagar, Bangalore - 560027 |
Approved |
| Ethics committee of Manipal Hospital&Manipal Heart Foundation,Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Solid Tumors, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
AH111585 (18F) Injection |
370 MBq |
| Comparator Agent |
N/A |
N/A |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
·The subject has been diagnosed with at least one solid primary or metastatic tumor greater than or equal to 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, H&N, and breast cancers.
·The subject is undergoing therapy for a malignant tumour with non-curative intent.
·The subject has received clinical routine imaging diagnostic work-up (e.g., CT with or without contrast,magnetic resonance imaging [MRI] with or without contrast, bone scintigraphy, X-ray, Mammography, [18F] FDG PET) within 8 weeks prior to the first [18F]AH111585 PET scan.
·The subject has the following baseline serum biochemistry and haematology values: blood urea nitrogen (BUN) value and serum creatinine (sCr) value of less than or equal to 1.5 of the upper normal limit; prothrombin time (PTT) and activated partial thromboplastin time (aPTT) within normal limits; haemoglobin value of >9 g/dL;and platelet count of >75,000 x 106/L.
·The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care, i.e. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2.
·Endocrine therapy is permitted provided that it has been initiated greater than or equal to 1 month prior to the first AH111585 imaging therapy and the treatment continues at least through the second AH111585 imaging session. |
|
| ExclusionCriteria |
| Details |
·The subject has received another IMP within 30 days before the first administration of AH111585 (18F) Injection, will receive another IMP during or between the 2 administrations of AH111585 (18F) Injection or plans to receive an IMP within 1 week after the second administration of AH111585 (18F) Injection.
·The subject has known hyper- or hypo-coagulation syndromes. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Haemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.
·The subject has received chemotherapy within 2 weeks, or received radiotherapy, surgery or any other treatment against cancer (with the exception of endocrine therapy) within 4 weeks prior to the first [18F]AH111585 PET scan.
·The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer (with the exception of endocrine therapy) between the first and second [18F]AH111585 PET scans.
·The subject's target tumour has been biopsied <4 weeks prior to the first [18F]AH111585 PET scan (not applicable for the immuno-histochemistry group) or is scheduled to undergo biopsy for the target tumour between the first and second [18F]AH111585 PET scans. Subjects in the immuno-histochemistry group may not have had the target tumour biopsied less than or equal to 1 week prior to the first [18F]AH111585 PET scan.
·The subject has intra-hepatic tumour(s) only (without extra-hepatic tumour).
·The subject has known diagnosis of human immunodeficiency virus (HIV) infection or hepatitis B-or C-type virus infection.
·The subject is being treated with heparin or warfarin. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the test-retest reproducibility of [18F]AH111585 uptake by solid tumors following intravenous administration of AH111585 (18F) Injection via PET imaging. |
Imaging takes approximately 65 minutes per imaging session |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To assess the image quality and lesion detectability of [18F]AH111585 as a function of administered
activity, by temporal segmentation. |
Post injection |
|
Target Sample Size
Modification(s)
|
Total Sample Size="45"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
06/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
23/06/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sharma et al, European Journal of Nuclear Medicine Molecular Imaging (2012), 39 (Suppl 2), S155-S303 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This will be a global study in up to 15 centres. The objective of the study is to assess the test-retest reproducibility of PET imaging using AH111585 (18F) Injection. Assessment of the test-retest reproducibility will be on measurements obtained for each targeted tumor lesion and the extent of the difference between SUV measurements of AH111585 (18F) uptake following injection of AH111585 (18F). Patients are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions. A total of up to 35 patients from India could be included in the study as per the approval from DCGI. Date of enrollment for Indian patients will occur after 01 October 2010. |