Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC

Weill Cornell Medicine (WCM)

Status and phase: Not yet enrolling; Phase 2

Conditions: Meningioma

Treatments: Drug: Ga-68-DOTATOC; Drug: Ga-68- DOTATATE

Study type: Interventional

Funder types: Other

Identifiers

NCT04298541

19-10021002

Details and patient eligibility

About

The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.

Full description

The investigator is proposing a direct comparison of Ga-68-DOTATATE and -DOTATOC in a pilot cohort of patients with meningioma, and hypothesize non-inferiority of DOTATOC. This pilot study will form the basis for a subsequent prospective clinical trial and will allow us to optimize our existing imaging protocols, while developing a more cost-effective protocol.

Primary Objectives:

• Optimize the Ga-68-DOTATOC PET/CT protocol.
• Compare Ga-68-DOTATATE PET and -DOTATOC PET/CT in patients with meningioma.

Secondary Objectives

• Correlate Ga-68-DOTATATE PET and -DOTATOC PET/CT with clinical and pathological characteristics

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with clinically suspected meningioma
• Patients planned for surgery - undergoing preoperative workup
• No contraindications to either radiotracer

Exclusion criteria

• Age less than 18 years
• Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Patients with Meningioma

Experimental group

Description:

Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.

Treatment:

Drug: Ga-68- DOTATATE

Drug: Ga-68-DOTATOC