Clinical trial NCT05186610: FDG PET/CT and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma
Official title: Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Positron Emission Tomography Computed Tomography
Image-Guided Biopsy
Fluorodeoxyglucose F18
Biopsy-Core Needle
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2022-01-11
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive participants presenting either with clinical suspicion of lymphomatous etiology at initial documentation or follow-up PET/CT scan during interim evaluation or at the end of therapy in pathologically proven lymphomatous etiology were included. All the patients underwent whole-body FDG PET/CT imaging and the patients with a lesion suspicious for lymphomatous involvement on FDG PET/CT imaging were recruited for PET/CT guided biopsy.

Brief summary: FDG-PET/CT is an established modality in various stages of management of lymphoma but definitive information regarding the diagnosis, prognostication, and further management is provided by histopathological examination. Combining the two modalities may provide an incremental benefit by identifying better sites for targetting biopsy and for better verification of sites and causes of FDG uptake seen during PET/CT.

Detailed description: Written informed consent was obtained from all the participants for PET/CT-guided biopsy. The procedure details, related risks, and benefits were explained to all the participants. A multidisciplinary team including hemato-oncologists, nuclear medicine physicians, and pathologists were involved in the project. A hemato-oncologist decided the biopsy indication after discussing it with the nuclear medicine physician. FDG avid lesions in a clinically suspected case of lymphoma or a suspicious, residual FDG avid lesion detected at the time of follow-up PET/CT imaging in a patient with a prior diagnosis of lymphoma were sampled. The per and post-procedural complications and management were maintained in the institutional PET data registry and the final histopathological diagnosis obtained was also collected.

Eligibility criteria: Inclusion Criteria:

* FDG avid lesion in a clinically suspected case of lymphoma.
* Suspicious, residual FDG avid lesion detected at the time of follow-up PET/CT imaging in a patient with a prior diagnosis of lymphoma either at the end-of-treatment or during surveillance.

Exclusion Criteria:

* Deranged coagulation profile.
* Inaccessibility of the lesion for a percutaneous biopsy.
* Resolution of the lesion at the time of biopsy planning.
* Participant is not willing for the procedure.
* Pregnant females and participants less than 18 years of age.

Primary outcomes:
measure: The yield of FDG PET/CT guided metabolic biopsy in lymphoma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Nuclear Medicine, PGIMER
state: Chandīgarh
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Rajender Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: