Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01755650
Other study ID # 11/31
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date October 2011
Est. completion date November 3, 2017

Study information

Verified date September 2023
Source Peter MacCallum Cancer Centre, Australia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date November 3, 2017
Est. primary completion date November 3, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Written informed consent obtained prior to any protocol-specific procedures - Male and female patients with histologically confirmed squamous cell carcinoma - At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care - Age >/= 18 years - Life expectancy >/= 3 months - ECOG Performance score of 0-2 Exclusion Criteria: - Pregnant or breastfeeding females - Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan - Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study - Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
18F FPM


Locations

Country Name City State
Australia Peter MacCallum Cancer Centre East Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest. 10, 30, 60 and 120 minutes post 18F FPM administration
Secondary Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration. 30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Secondary Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose 10, 30, 60 and 120 minutes post 18F FPM administration
See also
  Status Clinical Trial Phase
Terminated NCT02213133 - Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas Phase 2
Not yet recruiting NCT04533321 - A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Active, not recruiting NCT01232374 - Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma Phase 2
Withdrawn NCT01148082 - School Response to Families Who Have Children With Cancer N/A
Completed NCT01208883 - A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer Phase 1
Completed NCT01089803 - Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer N/A
Terminated NCT00707655 - Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy Phase 1/Phase 2
Completed NCT00586040 - Photochemical Tissue Bonding Phase 2
Completed NCT00793169 - Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Completed NCT01127737 - Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients N/A
Completed NCT00409565 - A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00176267 - Paclitaxel, Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer Phase 2
Terminated NCT04685798 - Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT N/A
Recruiting NCT04370587 - A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04475952 - Early Diagnosis of Upper Digestive Tract Disease
Recruiting NCT04435938 - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck Phase 2
Not yet recruiting NCT05852665 - Buccal Cancer Resection Ultrasound Guided N/A
Recruiting NCT05048459 - Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease N/A
Suspended NCT03952585 - De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer Phase 2/Phase 3