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CTRI Number  CTRI/2023/03/050433 [Registered on: 07/03/2023] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   PET IN OVARIAN CARCINOMA: AN IAEA INTERNATIONAL COOPERATIVE STUDY  
Scientific Title of Study   PET IN OVARIAN CARCINOMA (POCA): AN IAEA INTERNATIONAL COOPERATIVE STUDY (E.1.30.50) 
Trial Acronym  POCA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harmandeep Singh 
Designation  Associate Professor 
Affiliation  PGIMER 
Address  Department of Nuclear Medicine, PGIMER, Sector-12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  drharmandeepsingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harmandeep Singh 
Designation  Associate Professor 
Affiliation  PGIMER 
Address  Department of Nuclear Medicine, PGIMER, Sector-12, Chandigarh


CHANDIGARH
160012
India 
Phone    
Fax    
Email  drharmandeepsingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harmandeep Singh 
Designation  Associate Professor 
Affiliation  PGIMER 
Address  Department of Nuclear Medicine, PGIMER, Sector-12, Chandigarh


CHANDIGARH
160012
India 
Phone    
Fax    
Email  drharmandeepsingh@gmail.com  
 
Source of Monetary or Material Support  
International Atomic Energy Agency (IAEA), Vienna International Centre, PO Box 100, 1400 Vienna, Austria. 
 
Primary Sponsor  
Name  International Atomic Energy Agency (IAEA) 
Address  Vienna International Centre, PO Box 100, 1400 Vienna, Austria. 
Type of Sponsor  Contract research organization 
 
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 Harmandeep Singh  PGIMER  PET center, Department of Nuclear Medicine, Nehru Hospital, Sector-12, Chandigarh-160012
Chandigarh
CHANDIGARH 
7087003374

drharmandeepsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Inclusion criteria:
1. Patients with histologically proven diagnosis of ovarian carcinoma
2. Peritoneal carcinomatosis known or with high suspicion, without known further metastatic spread, before undergoing debulking surgery
3. 18F-FDG PET/CT performed prior to surgery less than 4 weeks
4. Signature of informed consent to participate in the study
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Metastatic disease known apart from peritoneal carcinomatosis
2. Diabetic patients with bad control
3. Debulking surgery not indicated
4. Surgical contraindications
5. Unable to consent
6. Estimated glomerular filtration rate (eGFR) < 30
7. Claustrophobia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the diagnostic performance of 18F-FDG PET/CT and its comparison to conventional imaging for staging OC.  Within 4 weeks before surgery 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes include the assessment of prognostic value of different peritoneal carcinomatosis scoring systems and comparison with 18F-FDG PET/CT in ovarian cancer patients.
Performance of different PET systems and inter reader agreement (using cohen’s kappa) will also be assessed. 
Post surgery follow up 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3 
Date of First Enrollment (India)   01/04/2023 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Ovarian carcinomas (OC) are rarely diagnosed in the early stage, without peritoneal spread (<5% of cases) while more than 90% presents with spread to the peritoneum and beyond. Common metastatic sites include liver, lung, spleen, transmural involvement of intestine, and skeletal metastases as well as involvement of the inguinal, supraclavicular, and axillary nodes. Cytoreductive surgery and chemotherapy are standard of care treatment in OC. Laparotomy and conventional imaging play important role in the precise assessment of tumour extent (primary tumour and peritoneal sites, regional lymph nodes, and distant sites) and deciding for primary surgery or neoadjuvant treatment. However, several anatomic locations such as retro-hepatic areas, retroperitoneal spaces, porta hepatis, are difficult to explore and up to 30% of patients are understaged at laparotomy, due to unexpected peritoneal or extra-abdominal (nodal or extranodal) spread.

Therefore, accurate presurgical staging is essential. Contrast-enhanced CT (ceCT) is useful to detect peritoneal spread of tumour and metastatic lesions, but despite being considered the modality of choice, its accuracy in staging OC ranges from 53% to 92%. with limited ability to detect small cancer implants on bowel surfaces, mesentery and parietal peritoneum. MR imaging demonstrates advantages relative to ceCT in evaluating metastatic spread in OC due to its higher soft tissue contrast and lack of radiation exposure. On MRI, lesions may be obscured by spleen or distortion artifacts. Moreover, MR imaging does not overcome the problem of diagnosing lymph nodal and peritoneal sites of malignancy by size criteria. Currently, MR imaging could be considered a second-line technique, in patients with contraindications to ceCT and/or in patients with inconclusive ceCT findings.

Nearly 40% of relapses following primary treatment of epithelial ovarian cancer with surgery and chemotherapy for stage 3 disease ( Nearly 70% of cases at presentation ) are extra abdominal which will be missed by conventional radiological procedures like CT and MRI abdomen. There is a need for imaging modalities with better diagnostic accuracy in staging OC. Glucose transporter 1 (GLUT-1) over-expression and microvessel density/tumour proliferation lead to high 18F-FDG uptake in OC. There is a high chance of picking them up early in primary and relapse setting using PET which can modify the mode and intensity of treatment and improve survivals. Thereby, 18F- FDG PET/CT may overcome limitations of conventional imaging in the preoperative staging of OC

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patients. Various studies have evaluated the role of 18F-FDG PET/CT in evaluation of suspected OC, staging and most important, in biochemical recurrence proving its advantage over ceCT. 18F- FDG PET/CT has better diagnostic performance compared with conventional imaging for the evaluation of the lymph node involvement (even sub-cm nodes), extra-abdominal spread, and detection of unsuspected extra abdominal spread and other malignant tumours being a whole body technique, leading to upstaging of disease in a significant percentage of patients and alter therapeutic decision making. A study showed that the sensitivity of 18F-FDG PET and ceCT is not the same in the different portions of the abdominopelvic cavity. However, literature is still limited and 18F-FDG PET is not routinely used in staging OC. The present study aims to compare 18F- FDG PET/CT and ceCT in the presurgical evaluation of peritoneal carcinomatosis in ovarian cancer patients.


 
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