Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors

  • STATUS
    Recruiting
  • End date
    Mar 5, 2023
  • participants needed
    40
  • sponsor
    University Health Network, Toronto
Updated on 5 June 2022

Summary

The variable clinical outcome of patients with G2 & G3 well diff GEP-NETs makes the selection of an optimal treatment strategy challenging.

Initial data suggests that high DOTATATE uptake and low FDG uptake are suggestive of low grade disease, with an indolent course.

Conversely, low DT uptake and high FDG uptake are suggestive of high-grade/ aggressive disease.

G2/3 GEP NETs may be biologically diverse; clinically relevant cohort for dual-tracer PET imaging.

Our secondary objectives are

  1. To determine the distribution of PETNET scores derived from 18F-FDG & 68Ga-DT PET in patients with G2 & G3 well diff GEP-NETs.
  2. To determine the proportion of patients in whom the addition of 18F-FDG PET data results in a change in planned clinical management.

To assess intra-individual variability in SSTR expression & glucose metabolism (as seen on DT and FDG PET) across different tumor sites within the same patient.

2) To determine whether a correlation exists between tumor texture features on 68Ga-DT & FDG PET to tumor grade and Ki 67 index.

3) To assess for an association between tumor texture features on 68Ga-DT PET and glucose metabolism; and/or an association between tumor texture features on FDG PET and SSTR expression.

Description

The variable clinical outcome of patients with G2 and G3 well differentiated GEP-NETs makes the selection of an optimal treatment strategy challenging.

A subject with 68Ga-DOTATATE uptake on all lesions without FDG uptake is likely to have low-grade, metabolically inactive disease, leading to an indolent disease course and may also be a predictive biomarker in subjects being considered for PRRT.

Conversely, avidity on 18F-FDG PET/CT and non-avidity on 68Ga-DOTATATE may indicate a high-grade NET, and would predict resistance to PRRT, suggesting that a more "aggressive" approach with systemic chemotherapy might be beneficial.

Therefore, the prospective assessment of PETNET score in patients with G2 or G3 GEP NETs, which may be biologically diverse is the most clinically relevant group for dual-tracer PET imaging.

Primary Objectives:

  1. To determine the distribution of PETNET scores derived from 18F-FDG and 68Ga-DOTATATE PET/CT in patients with G2 and G3 well differentiated GEP-NETs.
  2. To determine the proportion of patients in whom the addition of 18F-FDG PET/CT data results in a change in planned clinical management.

Secondary Objectives:

  1. mTo determine whether there is intra-individual variability in somatostatin receptor expression and glucose metabolism (as seen on DOTATATE PET and FDG PET, respectively) across different tumor sites within the same patient.
  2. To determine whether a correlation exists between tumor texture features on 68Ga-DOTATATE PET and FDG PET to tumor grade and Ki67 index.
  3. To assess if an association exists between tumor texture features on 68Ga-DOTATATE PET and glucose metabolism; and/or an association between tumor texture features on FDG PET and somatostatin receptor expression.

Details
Condition Neuroendocrine Tumors
Treatment F18-FDG
Clinical Study IdentifierNCT04804371
SponsorUniversity Health Network, Toronto
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Has provided written informed consent prior to any study-related procedures
Is a male or a female of 18 years of age or older
Patients who already had/scheduled for a 68Ga-DOTATATE PET/CT scan
Has a gastro entero-pancreatic neuroendocrine neoplasm confirmed by histological criteria. Patients with unknown primaries clinically thought to be from gastroenteropancreatic source shall be eligible
Has a well differentiated tumour Grade 2-3 (WHO 2017)
Has a tumour with a proliferation index (Ki67 ≥3%) or in samples where the Ki67 antigen cannot be reliably quantified, a mitotic index ≥2 mitosis/10HPF (high power fields)
Treatment naïve patients and/or patient who have received any number of prior systemic therapy lines for metastatic disease and/or locally advanced inoperable tumor
Willing and able to comply with all study requirements, including timing and/or nature of required assessments
Women of child-bearing age will undergo a urine test to exclude pregnancy prior to PET

Exclusion Criteria

Patients with known lung neuroendocrine tumours or other proven non gastroenteropancreatic histologies are not eligible
Patients with any known hypersensitivity to FDG
Has a well differentiated neuroendocrine tumour Grade 1 (WHO 2017)
Has a poorly differentiated neuroendocrine carcinoma (WHO 2017)
Mixed neuroendocrine and non-neuroendocrine cancer
Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
Any patient who is pregnant
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note