NCT02666547

Brief Summary

This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or 18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent tumor.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

9.4 years

First QC Date

January 24, 2016

Last Update Submit

June 17, 2024

Conditions

Pathological Angiogenesis

Keywords

68Ga-NODAGA-RGD18F-FDG18F-FETPET/CTneoangiogenesis

Outcome Measures

Primary Outcomes (1)

  • Comparison of each method of imaging for detection of tumors

    To compare the capacity of each of the techniques and their combination to detect tumors, to determine the composition of these tumors (neoangiogenesis, metabolism, necrosis), their extension, the changes due to treatment

    within 10 days

Secondary Outcomes (2)

  • ROC analysis and comparison of areas under the curve

    Within 10 days

  • Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments

    within 10 days

Study Arms (1)

68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs

OTHER

Active Comparator: 68Ga-NODAGA-RGD radiotracer All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT or a 18F-FET PET/CT

Drug: 68Ga-NODAGA-RGD PET/CTRadiation: 18F-FDG PET/CTRadiation: 18F-FET PET/CT

Interventions

68Ga-NODAGA-RGD PET/CTDRUG

200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull

68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs
18F-FDG PET/CTRADIATION

3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body

68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs
18F-FET PET/CTRADIATION

200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull

68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≤ 85 years old
  • Karnofsky index: ≥ 80%
  • Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and for which a 18F-FDG (or a 18F-FETfor glioma) is indicated : (1) glioma (WHO I, II-IV), (2) malignant melanoma, (3) cancer of upper respiratory tract, (4) breast cancer,(5) bone metastasis, (6) ovarian cancer, (7) lung cancer,(8) non-Hodgkinian malignant lymphoma with extra- lymphatic nodes extension, (9) neuroendocrine tumors, (10) pancreatic cancer,(11) oesophagus cancer,(12) stomach cancer. 10 patients will be included per type of cancer.
  • Informed consent signed

You may not qualify if:

  • Incapacity to sign the informed consent
  • Pregnancy, breastfeeding
  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois, Nuclear Medicine

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • Durante S, Dunet V, Gorostidi F, Mitsakis P, Schaefer N, Delage J, Prior JO. Head and neck tumors angiogenesis imaging with 68Ga-NODAGA-RGD in comparison to 18F-FDG PET/CT: a pilot study. EJNMMI Res. 2020 May 7;10(1):47. doi: 10.1186/s13550-020-00638-w.

    PMID: 32382869RESULT

  • Dietz M, Dunet V, Mantziari S, Pomoni A, Dias Correia R, Testart Dardel N, Boughdad S, Nicod Lalonde M, Treglia G, Schafer M, Schaefer N, Prior JO. Comparison of integrin alphavbeta3 expression with 68Ga-NODAGA-RGD PET/CT and glucose metabolism with 18F-FDG PET/CT in esophageal or gastroesophageal junction cancers. Eur J Hybrid Imaging. 2023 Feb 1;7(1):3. doi: 10.1186/s41824-023-00162-9.

    PMID: 36720731DERIVED

MeSH Terms

Conditions

Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

MetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John O Prior, MD, PhD

    Lausanne University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Nuclear Medicine Department

Study Record Dates

First Submitted

January 24, 2016

First Posted

January 28, 2016

Study Start

March 1, 2014

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)