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Clinical study to know the role of PET CT in assessing response to chemoradiotherapy prior to surgery and assessment of distant spread in carcinoma gallbladder

ROLE OF PET CT IN RESPONSE EVALUATION FOLLOWING NEOADJUVANT THERAPY AND ASSESSMENT OF DISTANT METASTSASIS IN PATIENTS WITH CARCINOMA GALLBLADDER

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/03/004500
Enrollment
40
Registered
2014-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- carcinoma gallbladder

Interventions

Intervention1: PET CT: pet ct is done for assessment of distant metastasis, for response evaluation in patients receiving neoadjuvant therapy. Intervention2: PETCT: PET ct in done in patients of carc

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • All patients with gall bladder cancer, who are being administered neoadjuvant therapy. • All patients with gallbladder cancer who are being planned for surgery. • All patients with incidentally detected carcinoma gallbladder who are being planned for surgery. • Ability to understand and willingness to sign a written informed consent

Exclusion criteria

Exclusion criteria: a)Patient refuses consent. b)Poor performance status (ECOG â?? 3 and 4) c) Major co-morbid conditions such as cirrhosis, renal failure, uncontrolled hypertension or cardiac failure . d)Patients who have received chemotherapy/ radiotherapy within 12 months prior to study entry. e) Any evidence of metastasis to distant organs (liver, lung, peritoneum,brain, bone etc). f) Non-contiguous liver metastasis (M1 disease). g) Major vascular involvement such as proper hepatic artery involvement and main portal vein involvement (T4 â?? inoperable disease). h) Periaortic, Pericaval, Superior mesenteric artery and/or Celiac artery lymph node involvement (N2 disease) â?? confirmed by

Design outcomes

Primary

MeasureTime frame
1) To compare PET-CT, conventional imaging and histopathology in assessing response to neoadjuvant therapy in carcinoma gallbladder 2) To assess distant metastasis using preoperative PET-CT and correlate this with conventional imaging, laparoscopic staging, histopathology and intraoperative findingsTimepoint: 1 year 9 months—

Secondary

MeasureTime frame
To assess distant metastasis using preoperative PET-CT and correlate this with conventional imaging, laparoscopic staging, histopathology and intraoperative findingsTimepoint: 1 year 9 months—

Countries

India

Contacts

Public ContactV Arun Kumar

AIIMS

peush_sahni@hotmail.com9999646488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026