⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)

Official Title: 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)

Study ID: NCT04849247

Study Description

Brief Summary: This is a Phase I, first-in-human study to evaluate the safety and efficacy of the 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI theranostic pair in patients with various types of cancer (locally advanced or metastatic cancer).

Detailed Description: This is a Phase I, first-in-human study to evaluate the safety and efficacy of the 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI theranostic pair in patients with various types of cancer. PET imaging using 68Ga-DOTA-FAPI will be used to diagnose patients who are eligible for the 177Lu-DOTA-FAPI. The overall purpose of this study is to identify the dose limiting toxicity (DLT) and recommended phase 2 dose (RP2D) of 177Lu-DOTA-FAPI. A 3+3 study design in is proposed to identify the RP2D of 177Lu-DOTA-FAPI. An expansion group will receive the RP2D in order to obtain initial estimates of response and additional information on safety of 177Lu-DOTA-FAPI. The hypotheses of this phase I study are that a) 68Ga-DOTA-FAPI will detect lesions in patients with various types of locally advanced or metastatic cancer. b) the theranostic pair 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI will be safe and well tolerated c) we will be able to identify a Recommended Phase 2 Dose (RP2D) for 177Lu-DOTA-FAPI therapy to be used in subsequent Phase II trials.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

First affiliated hospital of xiamen university, XiaMen, Fujian, China

Contact Details

Name: Long Sun, PhD

Affiliation: The First Affiliated Hospital of Xiamen University

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: