FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/107336 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   A study using copper based radiotracer PET CT scans to assess oxygen levels in tumors and predict treatment outcomes in patients with head and neck and lung cancer  
Scientific Title of Study   A longitudnal study to evaluate the prognostic potential of hypoxia estimation by 64 Copper ATSM PET CT in head and neck malignacies and NSCLC lung. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AVS Anil Kumar 
Designation  Professor  
Affiliation  Army Hospital RR Delhi 
Address  Dept of Nuclear Medicine Army Hospital RR Delhi Cantt Delhi

South West
DELHI
110010
India 
Phone  9673117027  
Fax    
Email  avsanil2002@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Braj Kishore Singh 
Designation  Associate Professor  
Affiliation  Army Hospital RR Delhi 
Address  Dept of Nuclear Medicine Army Hospital RR Delhi Cantt Delhi

South West
DELHI
110010
India 
Phone  8130666115  
Fax    
Email  mymailbox1410@gmail.com  
 
Details of Contact Person
Public Query  
Name  Braj Kishore Singh 
Designation  Associate Professor  
Affiliation  Army Hospital RR Delhi 
Address  Dept of Nuclear Medicine Army Hospital RR Delhi Cantt Delhi

South West
DELHI
110010
India 
Phone  8130666115  
Fax    
Email  mymailbox1410@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Army Hospital Research and Referal 
Address  Army Hospital Research and Referral Delhi Cantt New Delhi 110010 
Type of Sponsor  Other [Hospital and Research intitution under Ministry of Defence Govt of India] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Brig AVS Anil Kumar  Army Hospital Research And Referral  Department of Nuclear Medicine, Army Hospital Research And Referral, Delhi Cantt, New Delhi 110010
South West
DELHI 		 9673117027

avsanil2002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Army Hospital (R & R), Delhi Cantt   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Copper sixty four ATSM PET CT   Hypoxia imaging tracer for a total duration of eighteen months 
Comparator Agent  Fluorodeoxyglucose PET CT   Standard metabolic imaging for a total duration of eighteen months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients older than 18 years with biopsy proven advanced stage head and neck carcinoma or non small cell lung cancer who are candidates for radiotherapy or chemotherapy and willing to give written informed consent 
 
ExclusionCriteria 
Details  Pregnant or breastfeeding patients. Patients with poor glycaemic control. Patients unable to undergo PET CT scan. Patients unwilling to give written informed consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Progression free survival assessed as time from diagnosis to disease progression, relapse or death from any cause  At 6 months 12 months and 18 months after baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Maximum standardized uptake value of Copper sixty four ATSM & Fluorodeoxyglucose PET CT
 		 At Baseline  
Correlation of tracer uptake parameters including SUV max SUV mean hypoxic tumor volume & hypoxic burden with progression free survival
 		 At 6 months 12 months & 18 months after baseline 
Qualitative patterns of tracer uptake including homogeneous central marginal peripheral focal or no uptake  At Baseline  
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mymailbox1410@gmail.com].

  6. For how long will this data be available start date provided 31-01-2026 and end date provided 31-01-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Positron Emission Tomogaraphy Computed Tomography PET CT has emerged as a promising technique in oncological imaging for diagnosis , staging, therapy response and evaluation of recurrence in a number of maligancies. Although 18F FDG Fluro deoxy glucose is the major tracer used for oncological imaging, it has many inherent limitations. One of them is that, it cannot adequately differentiate areas of hypoxia within the tumour. Tumour hypoxia is considered as one of the major reasons for the failure of radiotherapy in many tumours including head and neck,lung,cervical and rectal tumours. The imaging with hypoxia seeking agents had started with introduction of 18F FMISO in 1990s. Subsequently in 1997, the first study to assesss hypoxia with copper ATSM was carried out.

Tumor hypoxia, characterized by inadequate oxygen supply, is a well established factor contributing to the aggressive behaviour of maligancies. It is associated with poor prognosis, increased resistance to conventional therapies such as radiotherapy and chemotherapy, and a higher likelihood of metastasis. The utilization of copper 64 diacetyl bis N4 methylthiosemicarbazone Cu 64 ATSM in the realm of lung,head and neck,cervical and rectal cancers has emerged as a promising avenue for enhancing the understanding and management  of tumor hypoxia. Traditional methods for assessing tumor hypoxia have limitations, often lacking the sensitivity or specificity required for effective clinical application. In this context, Cu 64 ATSM has garnered attention due to its potential as a positron emission tomography PET tracer the dellectively accumulates in hypoxic tissues. 
 
Close