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A phase II clinical trial to investigate the effect of pioglitazone on (18)F-FDG uptake in malignant lesions.

Han YH, Kwon SY, Kim J, Na CJ, Choi S, Min JJ, Bom HS, Kim YC, Oh IJ, Chae HJ, Lim ST, Sohn MH, Jeong HJ - EJNMMI Res (2015)

Bottom Line: Additionally, we classified the patients into two groups: the responder or non-responder group according to the presence of PIO effect on skeletal muscle.In hepatobiliary and pancreatic cancer, SUVmean and isocontour showed statistically significant increase in the presence of PIO.The test for safety and effectiveness of the new efficacy of Pioglitazone to diagnose the malignant tumor and inflammation in F-18 FDG positron emission tomography (PET) study, 12029.

View Article: PubMed Central - PubMed

Affiliation: Department of Nuclear Medicine, Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Cyclotron Research Center, Molecular Imaging and Therapeutic Medicine Research Center, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea. yani0878@hanmail.net.

ABSTRACT

Background: We found that (18)F-2-fluoro-2-deoxy-D-glucose ((18)F-FDG) uptake in malignant lesion was enhanced, and it was decreased in the inflammatory lesion after the use of peroxisome proliferator activated receptor-γ (PPAR-γ) agonist in our previous preclinical study. The purpose of this study was to investigate the effect of PPAR-γ agonist on malignant lesions in clinical (18)F-FDG positron emission tomography/computed tomography (PET/CT) imaging.

Methods: Forty-three patients were enrolled in this prospective study. We received the approval for the investigator-initiated trials for a phase II human clinical trial from the Korean Food and Drug Administration. On the first day, (18)F-FDG PET/CT images were acquired from patients without administration of pioglitazone (PIO), which is a PPAR-γ agonist. On the next day, (18)F-FDG PET/CT images were acquired once again from the same patients after administration of PIO. We measured the (18)F-FDG uptake in malignant lesions or inflammatory lesions from two (18)F-FDG PET/CT images. Four different PET parameters were used to compare between the two studies: SUVmax, SUVmean, average activity over 30 % of the isocontour (isocontour, Bq/mL), and isocontour-mediastinal activity (Bq/mL). Additionally, we classified the patients into two groups: the responder or non-responder group according to the presence of PIO effect on skeletal muscle. Furthermore, PET parameters of malignant lesions were analyzed based on the type of malignancy and were compared with those of inflammatory lesions.

Results: All four PET parameters of malignant lesions in the responder group showed increasing patterns after the use of PIO. In the subgroup analysis, the similar pattern was observed in gastrointestinal cancer. In hepatobiliary and pancreatic cancer, SUVmean and isocontour showed statistically significant increase in the presence of PIO. On the other hand, in the non-responder group, all four PET parameters showed decreasing patterns in both malignant and inflammatory lesions after the use of PIO. There was no statistically significant difference in PET parameters of malignant lesions in the non-responder group.

Conclusions: In this study, we found that PIO had the potential to increase (18)F-FDG uptake of malignant lesions in the patients who showed PIO effect on skeletal muscle. Contrary to our preclinical studies, clinical results had limitations to evaluate malignant lesions in non-responder group. Further larger-scale studies are necessary to elucidate the potential role of PIO on (18)F-FDG uptake in malignant or inflammatory lesions.

Trial registration: The test for safety and effectiveness of the new efficacy of Pioglitazone to diagnose the malignant tumor and inflammation in F-18 FDG positron emission tomography (PET) study, 12029.

No MeSH data available.


Related in: MedlinePlus

Measurement of the thigh muscle activity. Volume of interest is placed over an area of homogenous activity in the adductor muscles. Average activity in the thigh muscle is 3360.11 Bq/mL
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Fig1: Measurement of the thigh muscle activity. Volume of interest is placed over an area of homogenous activity in the adductor muscles. Average activity in the thigh muscle is 3360.11 Bq/mL

Mentions: We classified the patients into two groups: the responder or non-responder group according to the presence of PIO effect by measuring thigh muscle uptake. Average activity in thigh muscle was obtained from a volume of interest placed over an area of homogenous activity in the adductor muscles. Care was taken to avoid large vascular structures and any areas of increased 18F-FDG uptake that might represent malignancy. The way to measure thigh muscle activity is shown in Fig. 1.Fig. 1


A phase II clinical trial to investigate the effect of pioglitazone on (18)F-FDG uptake in malignant lesions.

Han YH, Kwon SY, Kim J, Na CJ, Choi S, Min JJ, Bom HS, Kim YC, Oh IJ, Chae HJ, Lim ST, Sohn MH, Jeong HJ - EJNMMI Res (2015)

Measurement of the thigh muscle activity. Volume of interest is placed over an area of homogenous activity in the adductor muscles. Average activity in the thigh muscle is 3360.11 Bq/mL
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4583556&req=5

Fig1: Measurement of the thigh muscle activity. Volume of interest is placed over an area of homogenous activity in the adductor muscles. Average activity in the thigh muscle is 3360.11 Bq/mL
Mentions: We classified the patients into two groups: the responder or non-responder group according to the presence of PIO effect by measuring thigh muscle uptake. Average activity in thigh muscle was obtained from a volume of interest placed over an area of homogenous activity in the adductor muscles. Care was taken to avoid large vascular structures and any areas of increased 18F-FDG uptake that might represent malignancy. The way to measure thigh muscle activity is shown in Fig. 1.Fig. 1

Bottom Line: Additionally, we classified the patients into two groups: the responder or non-responder group according to the presence of PIO effect on skeletal muscle.In hepatobiliary and pancreatic cancer, SUVmean and isocontour showed statistically significant increase in the presence of PIO.The test for safety and effectiveness of the new efficacy of Pioglitazone to diagnose the malignant tumor and inflammation in F-18 FDG positron emission tomography (PET) study, 12029.

View Article: PubMed Central - PubMed

Affiliation: Department of Nuclear Medicine, Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Cyclotron Research Center, Molecular Imaging and Therapeutic Medicine Research Center, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea. yani0878@hanmail.net.

ABSTRACT

Background: We found that (18)F-2-fluoro-2-deoxy-D-glucose ((18)F-FDG) uptake in malignant lesion was enhanced, and it was decreased in the inflammatory lesion after the use of peroxisome proliferator activated receptor-γ (PPAR-γ) agonist in our previous preclinical study. The purpose of this study was to investigate the effect of PPAR-γ agonist on malignant lesions in clinical (18)F-FDG positron emission tomography/computed tomography (PET/CT) imaging.

Methods: Forty-three patients were enrolled in this prospective study. We received the approval for the investigator-initiated trials for a phase II human clinical trial from the Korean Food and Drug Administration. On the first day, (18)F-FDG PET/CT images were acquired from patients without administration of pioglitazone (PIO), which is a PPAR-γ agonist. On the next day, (18)F-FDG PET/CT images were acquired once again from the same patients after administration of PIO. We measured the (18)F-FDG uptake in malignant lesions or inflammatory lesions from two (18)F-FDG PET/CT images. Four different PET parameters were used to compare between the two studies: SUVmax, SUVmean, average activity over 30 % of the isocontour (isocontour, Bq/mL), and isocontour-mediastinal activity (Bq/mL). Additionally, we classified the patients into two groups: the responder or non-responder group according to the presence of PIO effect on skeletal muscle. Furthermore, PET parameters of malignant lesions were analyzed based on the type of malignancy and were compared with those of inflammatory lesions.

Results: All four PET parameters of malignant lesions in the responder group showed increasing patterns after the use of PIO. In the subgroup analysis, the similar pattern was observed in gastrointestinal cancer. In hepatobiliary and pancreatic cancer, SUVmean and isocontour showed statistically significant increase in the presence of PIO. On the other hand, in the non-responder group, all four PET parameters showed decreasing patterns in both malignant and inflammatory lesions after the use of PIO. There was no statistically significant difference in PET parameters of malignant lesions in the non-responder group.

Conclusions: In this study, we found that PIO had the potential to increase (18)F-FDG uptake of malignant lesions in the patients who showed PIO effect on skeletal muscle. Contrary to our preclinical studies, clinical results had limitations to evaluate malignant lesions in non-responder group. Further larger-scale studies are necessary to elucidate the potential role of PIO on (18)F-FDG uptake in malignant or inflammatory lesions.

Trial registration: The test for safety and effectiveness of the new efficacy of Pioglitazone to diagnose the malignant tumor and inflammation in F-18 FDG positron emission tomography (PET) study, 12029.

No MeSH data available.


Related in: MedlinePlus